MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2015-05-21 for DRIVE MEDICAL RTL10400 manufactured by Unknown.
[22252686]
Drive medical received notice from an end user regarding an adverse incident regarding crutches that drive medical imports and distributes. Drive medical contacted the end user to gather more information. End user was using the crutches when one of the two crutches allegedly gave way and end user re-injured his foot. This report is based on information provided by the end user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2015-00012 |
| MDR Report Key | 4787828 |
| Report Source | * |
| Date Received | 2015-05-21 |
| Date of Report | 2015-04-23 |
| Date of Event | 2015-04-06 |
| Date Facility Aware | 2015-04-23 |
| Date Added to Maude | 2015-05-21 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE MEDICAL |
| Generic Name | CRUTCHES |
| Product Code | IPR |
| Date Received | 2015-05-21 |
| Model Number | RTL10400 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-21 |