MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-29 for DRIVE 10403 manufactured by Fort Metal Plastic Co., Ltd..
[83859575]
(b)(4) is the initial importer of the device which is a crutch. Forearm crutch allegedly broke at the 5th hole from the bottom during use. End-user reopened incision on recently amputated left leg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2017-00071 |
| MDR Report Key | 6826647 |
| Date Received | 2017-08-29 |
| Date of Report | 2017-08-01 |
| Date of Event | 2017-08-01 |
| Date Facility Aware | 2017-08-01 |
| Report Date | 2017-08-29 |
| Date Reported to FDA | 2017-08-29 |
| Date Reported to Mfgr | 2017-08-29 |
| Date Added to Maude | 2017-08-29 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | 2017-08-29 |
| Model Number | 10403 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FORT METAL PLASTIC CO., LTD. |
| Manufacturer Address | YI HE CIVIL AFFAIRS INDUSTRIAL GUONGDONG GUANGDONG, 516023 CH 516023 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-29 |