MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-07-05 for ROLLATOR UNAVAILABLE manufactured by Medical Depot, Inc (d/b/a Drive Medical Design & Mfg).
[3566290]
Pt's daughter called in march to say hinge on rollator was broken. She was told part was on backorder. It was understood that if part was not working not to use it. Rollator continued to be used while waiting for replacement part and pt then fell with rollator. We do not believe it was a malfunction, however, since the pt was aware of the fact that product needed a part, we believe that this incident was a user error.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2006-00002 |
| MDR Report Key | 3127084 |
| Report Source | 04 |
| Date Received | 2006-07-05 |
| Date of Report | 2006-05-27 |
| Date of Event | 2006-05-31 |
| Date Mfgr Received | 2006-05-27 |
| Date Added to Maude | 2013-05-24 |
| 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 | ROLLATOR |
| Generic Name | NONE |
| Product Code | NXE |
| Date Received | 2006-07-05 |
| Model Number | UNAVAILABLE |
| Catalog Number | UNAVAILABLE |
| Lot Number | UNAVAILABLE |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL DEPOT, INC (D/B/A DRIVE MEDICAL DESIGN & MFG) |
| Manufacturer Address | PORT WASHINGTON NY 11050 US 11050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2006-07-05 |