MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-26 for CLIP-ON BITEGUARD P/N KZ200693 H45521CB manufactured by Inoris Medical Sp. Z.o.o..
| Report Number | MW5087646 |
| MDR Report Key | 8739576 |
| Date Received | 2019-06-26 |
| Date of Report | 2019-06-24 |
| Date of Event | 2019-06-19 |
| Date Added to Maude | 2019-06-27 |
| 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 |
| 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 | CLIP-ON BITEGUARD |
| Generic Name | ENDOSCOPIC BITE BLOCK |
| Product Code | MNK |
| Date Received | 2019-06-26 |
| Model Number | P/N KZ200693 |
| Catalog Number | H45521CB |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INORIS MEDICAL SP. Z.O.O. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2019-06-26 |