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 |