MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-04 for CAREGUARD 96-2 manufactured by Invacare Corporation.
[177600859]
Patient was utilizing the shower chair for bathing with significant other standing by to assist. The legs on the chair spread too widely, resulting in the chair "snapping" and breaking while the patient was in it. Patient was assisted by significant other, thus preventing a fall from the breaking and collapsing of the chair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9665134 |
| MDR Report Key | 9665134 |
| Date Received | 2020-02-04 |
| Date of Report | 2019-12-06 |
| Date of Event | 2019-11-27 |
| Report Date | 2019-12-06 |
| Date Reported to FDA | 2019-12-06 |
| Date Reported to Mfgr | 2020-02-04 |
| Date Added to Maude | 2020-02-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | CAREGUARD |
| Generic Name | CHAIR, ADJUSTABLE, MECHANICAL |
| Product Code | INN |
| Date Received | 2020-02-04 |
| Model Number | 96-2 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE CORPORATION |
| Manufacturer Address | 39400 TAYLOR PKWY NORTH RIDGEVILLE OH 44035 US 44035 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-04 |