MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-22 for DRIVE MEDICAL 10405 manufactured by Unk.
[67946371]
(b)(4) healthcare received a notice regarding the incident from the enduser, involving a steel forearm crutch, a product imported and distributed by (b)(4). While using the crutches to get to his car, the crutches allegedly broke causing the enduser to fall. He went to the emergency room due to pain, which allegedly got progressively worse. (b)(4) has been reaching out to the claimant for the product information to further investigate the complaint, however, this information is still not available at this time. Therefore we are unable to identify the manufacturer. This report is based on the information that was provided by the enduser.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2017-00018 |
| MDR Report Key | 6348904 |
| Date Received | 2017-02-22 |
| Date of Report | 2017-01-25 |
| Date of Event | 2017-01-24 |
| Date Facility Aware | 2017-01-25 |
| Report Date | 2017-02-22 |
| Date Reported to FDA | 2017-02-22 |
| Date Added to Maude | 2017-02-22 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE MEDICAL |
| Generic Name | CRUTCH |
| Product Code | IPR |
| Date Received | 2017-02-22 |
| Model Number | 10405 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-22 |