MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-09 for CRUTCHES IV1507003652 manufactured by Drive.
[33555116]
Patient had foot surgery on (b)(6) 2015. She was given crutches thru the dme provider. On (b)(6) 2015 the rubber on the bottom of the crutches wore thru, causing the patient to fall. Patient was seen in the emergency dept and has been having pain since.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058478 |
| MDR Report Key | 5294176 |
| Date Received | 2015-12-09 |
| Date of Report | 2015-12-09 |
| Date of Event | 2015-11-24 |
| Date Added to Maude | 2015-12-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | 0 |
| Brand Name | CRUTCHES |
| Generic Name | CRUTCHES |
| Product Code | INP |
| Date Received | 2015-12-09 |
| Model Number | IV1507003652 |
| ID Number | 2238312660 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRIVE |
| Manufacturer Address | PORT WASHINGTON NY 11050 US 11050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-09 |