MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-18 for INVACARE SHOWER GEL 9670U manufactured by Invacare Corporation Tw.
| Report Number | MW5087452 |
| MDR Report Key | 8712373 |
| Date Received | 2019-06-18 |
| Date of Report | 2019-06-14 |
| Date Added to Maude | 2019-06-19 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | INVACARE SHOWER GEL |
| Generic Name | AID, TRANSFER |
| Product Code | IKX |
| Date Received | 2019-06-18 |
| Model Number | 9670U |
| Lot Number | M 20105 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE CORPORATION TW |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-06-18 |