MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-28 for DRIVE RTL1200277RA manufactured by Unknown.
[140210086]
(b)(4) is the initial importer or the device which is a toilet seat. Product has not been returned to (b)(4) for evaluation. After use the consumer brushed the back of her right leg against "a wing nut:" in the center front of the seat. The user reported that the sharp, uneven surface and side of the screw cut into her calf causing profuse bleeding and a visit to the emergency center. The piece of torn skin was reportedly surgically removed, the wound cleaned and bandaged and a tetanus booster administered. Our tech department has advised that the device should have a locking mechanism in this position for safety made completely of rounded plastic with no sharp edges, no metal screws or hardware.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2019-00014 |
| MDR Report Key | 8461375 |
| Date Received | 2019-03-28 |
| Date of Report | 2019-03-28 |
| Date of Event | 2019-01-25 |
| Date Facility Aware | 2019-02-14 |
| Report Date | 2019-03-28 |
| Date Reported to FDA | 2019-03-28 |
| Date Added to Maude | 2019-03-28 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRIVE |
| Generic Name | RAISED TOILET SEAT |
| Product Code | ILS |
| Date Received | 2019-03-28 |
| Model Number | RTL1200277RA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-03-28 |