MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-08-05 for BATH-BOARD MARINA H112 FACELIFT EU:1541330 1541330 manufactured by Invacare Germany, Aquatec.
| Report Number | 3007231105-2019-00003 |
| MDR Report Key | 8859712 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-08-05 |
| Date of Report | 2019-07-18 |
| Date of Event | 2019-06-28 |
| Date Mfgr Received | 2019-07-18 |
| Device Manufacturer Date | 2016-12-01 |
| Date Added to Maude | 2019-08-05 |
| 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 Contact | MR. JASON FIEST |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE GERMANY, AQUATEC |
| Manufacturer Street | ALEMANNENSTRASSE 10 |
| Manufacturer City | 88316 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 88316 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BATH-BOARD MARINA H112 FACELIFT |
| Generic Name | ADAPTOR, HYGIENE |
| Product Code | ILS |
| Date Received | 2019-08-05 |
| Model Number | EU:1541330 |
| Catalog Number | 1541330 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE GERMANY, AQUATEC |
| Manufacturer Address | ALEMANNENSTRASSE 10 ?ISNY 88316 GM 88316 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-08-05 |