MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-11 for INVACARE I-CLASS HEAVY DUTY TRANSFER BENCH 9670U manufactured by Invacare Corporation (tw).
| Report Number | 9181055 |
| MDR Report Key | 9181055 |
| Date Received | 2019-10-11 |
| Date of Report | 2019-09-24 |
| Date of Event | 2019-04-01 |
| Report Date | 2019-09-24 |
| Date Reported to FDA | 2019-09-24 |
| Date Reported to Mfgr | 2019-10-09 |
| Date Added to Maude | 2019-10-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 I-CLASS HEAVY DUTY TRANSFER BENCH |
| Generic Name | AID, TRANSFER |
| Product Code | IKX |
| Date Received | 2019-10-11 |
| Catalog Number | 9670U |
| Lot Number | M 21109 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE CORPORATION (TW) |
| Manufacturer Address | 39400 TAYLOR PKWY NORTH RIDGEVILLE OH 44035 US 44035 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-11 |