MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-19 for DRIVE 10403 manufactured by Unknown.
[83095859]
(b)(6) is the initial importer of the device which is a forearm crutch. Drive was notified of the event through court paperwork. We are awaiting additional information from the attorney. The end-user was at home utilizing the forearm crutch when it allegedly buckled and broke in two. The end-user fell to the ground, injuring his left leg and causing pain in his hips, left leg, back, neck and left shoulder. He was transported to the er where he was treated for his injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2017-00070 |
| MDR Report Key | 6806225 |
| Date Received | 2017-08-19 |
| Date of Report | 2017-07-19 |
| Date of Event | 2016-10-26 |
| Report Date | 2017-08-17 |
| Date Reported to FDA | 2017-08-17 |
| Date Added to Maude | 2017-08-19 |
| 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 | ATTORNEY |
| 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 | DRIVE |
| Generic Name | CRUTCH |
| Product Code | IPR |
| Date Received | 2017-08-19 |
| Model Number | 10403 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-19 |