MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-12 for INNOWAVE PCF SONIC IRRIGATOR manufactured by Medisafe Uk Ltd..
| Report Number | 9617134-2019-00001 |
| MDR Report Key | 8693163 |
| Date Received | 2019-06-12 |
| Date of Report | 2019-06-12 |
| Date of Event | 2019-05-13 |
| Date Mfgr Received | 2019-05-13 |
| Date Added to Maude | 2019-06-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927453 |
| Manufacturer G1 | MEDISAFE UK LTD. |
| Manufacturer Street | TWYFORD RD./THE SNAP FACTORY BISHOP STORTFORD |
| Manufacturer City | HERTFORSHIRE HERTFORDS, CM233LJ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CM23 3LJ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INNOWAVE PCF SONIC IRRIGATOR |
| Generic Name | SONIC IRRIGATOR |
| Product Code | FLG |
| Date Received | 2019-06-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDISAFE UK LTD. |
| Manufacturer Address | TWYFORD RD./THE SNAP FACTORY BISHOP STORTFORD HERTFORSHIRE HERTFORDS, CM233LJ UK CM23 3LJ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-12 |