MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-13 for DRIVE MEDICAL 10400-1 manufactured by Zhongshan Bliss Medical Instrument Co., Ltd.
[31073616]
Drive medical received a notice from a provider regarding an incident which involves the crutch that drive medical imports and distributes. As the enduser was coming out of the house, the hand grips on both sides of the crutches gave out causing her to fall on her butt and hit her head and the left side of her shoulder on a concrete surface. This report is based on information provided by the enduser and the provider.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2015-00029 |
| MDR Report Key | 5221348 |
| Date Received | 2015-11-13 |
| Date of Report | 2015-09-15 |
| Date of Event | 2015-09-15 |
| Date Facility Aware | 2015-10-13 |
| Report Date | 2015-11-12 |
| Date Reported to FDA | 2015-11-12 |
| Date Reported to Mfgr | 2015-11-12 |
| Date Added to Maude | 2015-11-13 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | 2015-11-13 |
| Model Number | 10400-1 |
| Catalog Number | 10400-1 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZHONGSHAN BLISS MEDICAL INSTRUMENT CO., LTD |
| Manufacturer Address | 98 ZHAOYI ROAD DONGSHENG TOWN ZHONGSHAN CITY, GUANGDONG 528414 CH 528414 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-13 |