MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-01 for DRIVE RTL12505 manufactured by Unknown.
[140548848]
(b)(4) is the initial importer of the device which is a shower chair. The end-user discarded the chair. There are no pictures of the device. (b)(4) will be unable to evaluate the device. The device was purchased 3 months before it broke. It required assembly. It was adjustable for height and had grips for the floor. End-user claimed that the shower chair broke in half from side to side and shattered. The broken plastic injured his hip. The end-user went to his therapist after the incident. End-user is paralyzed on his left side sde due to a stroke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2019-00016 |
| MDR Report Key | 8471388 |
| Date Received | 2019-04-01 |
| Date of Report | 2019-04-01 |
| Date of Event | 2019-01-18 |
| Date Facility Aware | 2019-01-23 |
| Report Date | 2019-04-01 |
| Date Reported to FDA | 2019-04-01 |
| Date Added to Maude | 2019-04-01 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | BATH BENCH |
| Product Code | ILS |
| Date Received | 2019-04-01 |
| Model Number | RTL12505 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-01 |