MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-18 for DRIVE MEDICAL 10430-8 NA manufactured by Maxhealth Corp.
[2784051]
Drive medical has received a complaint from an pharmacy? S insurance company about an incident involving a crutch originally distributed by drive medical. It is alleged that the end user was using the crutch when it twisted causing the end user to fall. The claimant allegedly sustained a fracture at the base of the left metatarsal, bruising and contusion. The claimant? S attorney refused to release add? L info pertaining to the injuries. This mdr report is based on the insurance company complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2012-00009 |
| MDR Report Key | 2603276 |
| Date Received | 2012-05-18 |
| Date of Report | 2012-04-19 |
| Date of Event | 2011-12-03 |
| Report Date | 2012-05-19 |
| Date Reported to Mfgr | 2012-05-11 |
| Date Added to Maude | 2012-06-08 |
| 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 |
| Manufacturer Street | 99 SEAVIEW BLVD. |
| Manufacturer City | PORT WASHINGTON NY 11050 |
| Manufacturer Country | US |
| Manufacturer Postal | 11050 |
| Manufacturer G1 | MEDICAL DEPOT |
| Manufacturer Street | 99 SEAVIEW BLVD. |
| Manufacturer City | PORT WASHINGTON NY 11050 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11050 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE MEDICAL |
| Generic Name | EZ ADJUST ALUMINUM CRUTCHES |
| Product Code | NXE |
| Date Received | 2012-05-18 |
| Model Number | 10430-8 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 6 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAXHEALTH CORP |
| Manufacturer Address | TAIPEI HSIEN TAIWAN CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-05-18 |