MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-08-10 for DRIVER MEDICAL 10209RD-1 manufactured by Medical Depot Inc. (d/b/a Drive Medical Design And Mfg).
[694724]
The user allegedly was trying to sit on the rollator to test the product when the left caster fell out. She consequently fell backwards sustaining severe cuts on the right calf and right elbow. Medical attention was required.
Patient Sequence No: 1, Text Type: D, B5
[8129016]
All our rollators are distributed with all casters preinstalled. The front caster fork is installed to the frame by an axle bolt and lock washer. According to customer, this rollator had been used for demonstration in showrooms for more than two yrs. It appeared that the wheel came loose due to lack of maintenance.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2438477-2007-00002 |
| MDR Report Key | 893206 |
| Report Source | 08 |
| Date Received | 2007-08-10 |
| Date of Report | 2007-07-11 |
| Date of Event | 2007-07-11 |
| Date Mfgr Received | 2007-07-11 |
| Device Manufacturer Date | 2004-10-22 |
| Date Added to Maude | 2007-08-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | RICH KOLODNY |
| Manufacturer Street | 99 SEAVIEW BLVD |
| Manufacturer City | PORT WASHINGTON NY 11050 |
| Manufacturer Country | US |
| Manufacturer Postal | 11050 |
| Manufacturer Phone | 5169984600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVER MEDICAL |
| Generic Name | ROLLATOR |
| Product Code | NXE |
| Date Received | 2007-08-10 |
| Model Number | NA |
| Catalog Number | 10209RD-1 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 873740 |
| Manufacturer | MEDICAL DEPOT INC. (D/B/A DRIVE MEDICAL DESIGN AND MFG) |
| Manufacturer Address | PORT WASHINGTON NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-08-10 |