MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-06-08 for DRIVE MEDICAL 10210-2 manufactured by Medical Depot Inc. (d/b/a Drive Medical Design & Mfg).
[661265]
User allegedly was in the kitchen, walked down hallway and proceeded to go up approx nine (9) steps when allegedly the leg of the walker allegedly snapped and user tumbled down the stairway. User does not recall the fall. User broke his right hip and fractured his pelvic bone. Family members called 911. User was transported and admitted to hosp in 2007. After treatment and stabilization, user was then transported five days later to rehab. As of three days later, user was still in rehab.
Patient Sequence No: 1, Text Type: D, B5
[7981632]
The suspect device appeared to be used for a period of time. The right rear leg is broken off completely at where the lower rivet attached to the side cross bar. The folding/latching mechanism appeared to work properly. We believe that the device broke because the user applied weight to only one leg while walking on steps. Our product instruction has a warning for the user not to use on stairs or escalators.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2438477-2007-00001 |
| MDR Report Key | 863248 |
| Report Source | 08 |
| Date Received | 2007-06-08 |
| Date of Report | 2007-05-21 |
| Date of Event | 2007-05-10 |
| Date Mfgr Received | 2007-05-11 |
| Date Added to Maude | 2007-06-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | RICH KOLODNY |
| Manufacturer Street | 99 SEAVIEW BLVD. |
| Manufacturer City | PORT WASHINGTON NY 11050 |
| Manufacturer Country | US |
| Manufacturer Postal | 11050 |
| Manufacturer Phone | 5169984600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE MEDICAL |
| Generic Name | MECHANICAL WALKER |
| Product Code | NXE |
| Date Received | 2007-06-08 |
| Returned To Mfg | 2007-05-30 |
| Model Number | NA |
| Catalog Number | 10210-2 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 847439 |
| Manufacturer | MEDICAL DEPOT INC. (D/B/A DRIVE MEDICAL DESIGN & MFG) |
| Manufacturer Address | PORT WASHINGTON NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2007-06-08 |