MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-05 for WALKER MDS86410W5414 manufactured by Medline Industries, Inc..
[101501934]
Patient Sequence No: 1, Text Type: N, H10
[101501935]
Patient was walking into room and fell onto his back. The walker had not been put together properly. The wheels were attached to the back of the walker and the stoppers were on the front.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7312919 |
| MDR Report Key | 7312919 |
| Date Received | 2018-03-05 |
| Date of Report | 2018-01-30 |
| Date of Event | 2017-11-26 |
| Report Date | 2018-01-29 |
| Date Reported to FDA | 2018-01-29 |
| Date Reported to Mfgr | 2018-01-29 |
| Date Added to Maude | 2018-03-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALKER |
| Generic Name | TIPS AND PADS, CANE, CRUTCH AND WALKER |
| Product Code | INP |
| Date Received | 2018-03-05 |
| Catalog Number | MDS86410W5414 |
| Lot Number | 88517010016 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-05 |