MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-04-27 for DRIVE MEDICAL 750NB NA manufactured by Unknown.
[2687082]
Drive medical has received a complaint from an attorney about an incident involving a rollator, allegedly distributed by (b)(4). It is reported that the rollator buckled and bent causing the claimant to fall and sustain serious injuries requiring hospitalization and other care. This mdr report is based on the customer complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2012-00007 |
| MDR Report Key | 2556015 |
| Report Source | 99 |
| Date Received | 2012-04-27 |
| Date of Report | 2012-03-29 |
| Date Facility Aware | 2012-03-29 |
| Report Date | 2012-04-27 |
| Date Added to Maude | 2012-05-03 |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE MEDICAL |
| Generic Name | ROLLATOR |
| Product Code | NXE |
| Date Received | 2012-04-27 |
| Model Number | 750NB |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | UNKNOWN UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-04-27 |