MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-27 for INVACARE I-FIT SHOWER CHAIR 9780 manufactured by Unknown.
| Report Number | 1531186-2020-00008 |
| MDR Report Key | 9765068 |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-03 |
| Date of Event | 2019-12-31 |
| Date Facility Aware | 2020-02-03 |
| Date Added to Maude | 2020-02-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVACARE I-FIT SHOWER CHAIR |
| Generic Name | ADAPTOR, HYGIENE |
| Product Code | ILS |
| Date Received | 2020-02-27 |
| Model Number | 9780 |
| Catalog Number | 9780 |
| Lot Number | 09/03/08 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 11 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-27 |