MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-09 for DRIVE MEDICAL manufactured by Removed Industrial Co., Ltd..
[39986846]
Please note that this submission package was originally submitted on 12/31/2015 using the test site because i was unaware of the production site. It will be repackage and send through the production site on 03/09/2016.
Patient Sequence No: 1, Text Type: N, H10
[39986847]
Drive medical received a notice from a provider regarding an incident which involves the crutch which drive medical imports and distributes. On the third use of the crutch, the base/foot metal was sticking through which was brought by an allegedly worn out tips. As a result, the end user lost her balance and fell to the floor. She went to the hospital and had an mri done wherein the result shows she has a torn right achilles. This report is based on information provided by the end user and the provider.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2015-00037 |
| MDR Report Key | 5489651 |
| Date Received | 2016-03-09 |
| Date of Report | 2015-12-01 |
| Date of Event | 2015-11-24 |
| Date Facility Aware | 2015-12-02 |
| Report Date | 2015-12-31 |
| Date Reported to FDA | 2015-12-31 |
| Date Reported to Mfgr | 2015-12-31 |
| Date Added to Maude | 2016-03-09 |
| 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 | 2016-03-09 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REMOVED INDUSTRIAL CO., LTD. |
| Manufacturer Address | NORTH SIDE OF NO.6 TECH ROAD HIGH & NEW TECHNOLOGY ZONE HEYUAN CITY, GUANGDONG 517000 CH 517000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-09 |