MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-15 for DRIVE MEDICAL 10402-1 manufactured by Unknown.
[42850968]
(b)(6) received notice regarding the incident from the provider involving crutches, a product imported and distributed by drive medical. Allegedly the rubber part at the bottom of the crutch tore through, so when the enduser stepped onto the tile floor she slipped and landed on her broken foot. She went to the hospital and allegedly reinjured her broken foot. Due to lack of product information, we are unable to identify the nature of the defect for this product. This report is based on the information provided from the provider.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2016-00019 |
| MDR Report Key | 5583195 |
| Date Received | 2016-04-15 |
| Date of Report | 2016-03-17 |
| Date of Event | 2016-03-17 |
| Date Facility Aware | 2016-03-17 |
| Report Date | 2016-04-15 |
| Date Reported to FDA | 2016-04-15 |
| Date Added to Maude | 2016-04-15 |
| 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 |
| 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 | 2016-04-15 |
| Model Number | 10402-1 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-15 |