# Codebook: FDA reports on walkers and rollators (product codes ITJ and NXE) Written before any report in the set was coded. Mobility Atlas study, October 2026. ## Pool FDA MAUDE device reports filed under product code ITJ ("Walker, Mechanical", 21 CFR 890.3825) or NXE ("Walker, Mechanical, Poly Vinyl Chloride"), read in openFDA on 16 October 2026, that carry text: (a) every such report received 1 January 2019 to 31 December 2025 (786); (b) every such report received in 2026 from a maker other than Medline (77); (c) a systematic sample of 300 of the 4,124 reports with text that Medline filed in 2026 (50 consecutive reports at six evenly spaced positions of the openFDA result list). Pool: 1,163 reports. ## What you record for each report One line per report: `report_key,device,category,injury,fall,finding,note` ### DEVICE (one letter), from the report text; the brand line may be used when the text does not say - R: ROLLATOR: a walker with three or four wheels and hand brakes, usually with a seat ("rollator", "4-wheel walker with seat", "3-wheel walker"). - W: WALKER without hand brakes: a standard frame walker (pick-up) or a front-wheeled walker with two wheels or glides; hemi walkers and folding walkers. - K: KNEE WALKER or knee scooter. - P: OTHER mobility walker: posterior or gait trainer, upright walker, bariatric walker, walker attachment. - U: the report does not say what kind of walker. ### CATEGORY (one letter): what the report says went wrong. Precedence: the FIRST letter that applies wins. 1. B: BRAKES: the hand brakes or parking brakes failed, did not hold, did not release, the brake cable or lever broke or came loose, the walker rolled when braked. 2. S: SEAT: the seat, seat support, seat bar or backrest broke, collapsed or came loose, or the user fell while sitting on or getting onto the seat. 3. H: WHEEL: a wheel, caster, tire, axle, bearing or fork broke, came off, locked, wobbled or jammed. 4. F: FRAME OR FOLDING: the frame, a leg, a weld, a cross brace, a rivet or screw, a height adjustment button or pin, or the folding lock broke, bent, collapsed or released, or a leg would not lock. 5. G: HANDLE OR GRIP: a handle, handgrip or handle-height adjustment broke, came loose, slipped or turned. 6. T: TIPS AND GLIDES: a rubber tip, glide or ski wore through, came off or slipped. 7. P: PINCH OR CUT: a finger or skin was pinched, cut or scraped by the walker with no failure from 1-6. 8. L: FALL with no failure from 1-7 named (the user tripped, lost balance, the walker caught on a doorway or rug, stairs, curbs). 9. A: ASSEMBLY OR PACKAGING: missing parts, wrong parts, would not assemble, damaged on arrival, with no use event. 10. X: no device problem stated, or only labeling, cleaning, sales or delivery issues. 11. U: a device problem is alleged but you cannot tell which kind. - N: no event involving a walker, rollator or knee walker is described. ### FLAGS (y or n) - injury: the report states harm to the body or medical care (bruise, fracture, laceration, stitches, hospital, surgery, death). Pain alone counts as y. y when the event type is Death. - fall: the user fell or was thrown to the ground (a near fall caught by someone is n). ### FINDING (one letter): what the maker found, as the report states it - D: a fault was found or confirmed, or a part was replaced because it was faulty. - N: no fault found, worked as designed, or the cause was outside the device (misuse, wrong assembly by the user, used on stairs, weight over the limit, modification). - X: not evaluated, not returned, or nothing stated. ### note At most 15 words: the part, what made the choice hard. No quotes longer than 6 words. No personal details. ## Output format CSV with header `report_key,device,category,injury,fall,finding,note`, one row per report in your chunk, nothing else. Every report gets exactly one row.