MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-21 for DRIVE 12202KD-4 manufactured by Unknown.
[139540073]
Drive devilbiss healthcare is the initial importer of the device which is a bath chair. The chair was provided to him by the hotel he was visiting. The device is not available for evaluation. It is unclear if the device broke or was not set up properly. This is a legal claim. The end-user is an amputee. The right side legs gave out as he was using the chair in the shower. He fell. His stump hit the shower grate bar causing bruising and minor abrasions. He hurt his left hip and elbow. He waited two days to seek medical attention due to embarrassment. He went to the va where they checked the stump for infection. He went to physical therapy for the pain in his hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2019-00009 |
| MDR Report Key | 8441996 |
| Date Received | 2019-03-21 |
| Date of Report | 2019-03-21 |
| Date of Event | 2018-12-03 |
| Report Date | 2019-03-21 |
| Date Reported to FDA | 2019-03-21 |
| Date Added to Maude | 2019-03-21 |
| 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 | BATH CHAIR |
| Product Code | ILS |
| Date Received | 2019-03-21 |
| Model Number | 12202KD-4 |
| 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 | 2019-03-21 |