MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-06 for DRIVE 12203KD-1 manufactured by Unknown.
[173927143]
Drive devilbiss is the initial importer of the device which is a bath chair. The unit has not been returned for evaluation. End-user was in the shower seated on the chair when the legs bent. He fell and caught hiumself. His arm was sore. A couple of days later he went to a doctor for e-rays. He may have a hairline fracture of his left hand/arm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2020-00001 |
| MDR Report Key | 9553345 |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-11-29 |
| Date Facility Aware | 2019-12-04 |
| Report Date | 2020-01-06 |
| Date Reported to FDA | 2020-01-06 |
| Date Added to Maude | 2020-01-06 |
| 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 CHAIT |
| Product Code | ILS |
| Date Received | 2020-01-06 |
| Catalog Number | 12203KD-1 |
| 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 | 2020-01-06 |