MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-15 for DRIVE 10502-1 manufactured by Danyang Jumao.
[142039907]
(b)(6) is the initial importer of the device which is a crutch. The consumer received the crutch from a hospital. He noticed that the bolt on the crutch was missing. When he used the crutch it snapped. He fell. He fractured his leg in two additional places.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2019-00021 |
| MDR Report Key | 8516588 |
| Date Received | 2019-04-15 |
| Date of Report | 2019-04-15 |
| Date Facility Aware | 2019-03-11 |
| Report Date | 2019-04-15 |
| Date Reported to FDA | 2019-04-15 |
| Date Reported to Mfgr | 2019-04-16 |
| Date Added to Maude | 2019-04-15 |
| 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 |
| 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 |
| Generic Name | CRUTCH |
| Product Code | IPR |
| Date Received | 2019-04-15 |
| Model Number | 10502-1 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 15 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DANYANG JUMAO |
| Manufacturer Address | 36 DANYANG RD DANYANG CITY JIANGSU PROVENCE, JIANGSU 212300 CH 212300 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-15 |