MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-10-04 for DRIVE MEDICAL R728RD OR R8RD NA manufactured by Unk.
[2918449]
(b)(4) has received updated information from an attorney on the patient injury from a previous complaint involving a rollator allegedly distributed by (b)(4). It is alleged that the claimant was sitting on the rollator when the right front wheel broke off causing her to fall and break her left humerus. (b)(4) had reached out to the claimant? S attorney to have the alleged product returned for evaluation. But our request was refused. Attorney did send photos and medical records. It is reported that the patient was admitted to a rehab unit for five (5) days and discharged in stable condition. This mdr report is based on the complaint from claimant? S attorney and relating medical records.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2012-00022 |
| MDR Report Key | 2794894 |
| Report Source | 99 |
| Date Received | 2012-10-04 |
| Date of Report | 2012-09-04 |
| Date of Event | 2011-12-31 |
| Date Facility Aware | 2012-09-04 |
| Report Date | 2012-10-04 |
| Date Added to Maude | 2012-10-22 |
| 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 | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE MEDICAL |
| Generic Name | ROLLATOR |
| Product Code | NXE |
| Date Received | 2012-10-04 |
| Model Number | R728RD OR R8RD |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-10-04 |