MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-28 for BEAVER? AND EDGEAHEAD SAFETY SIDEPORT MVR KNIFE, 1.15 MM, 45 DEGREES (20G) 378231 manufactured by Beaver Visitec International, Inc.
| Report Number | 1211998-2020-00249 |
| MDR Report Key | 9893249 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-28 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-04-29 |
| Date Mfgr Received | 2019-05-06 |
| Device Manufacturer Date | 2019-02-08 |
| Date Added to Maude | 2020-03-28 |
| 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 | MS. ROBIN ROWE |
| Manufacturer Street | 500 TOTTEN POND RD 10 CITYPOINT |
| Manufacturer City | WALTHAM, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 8065779 |
| Manufacturer G1 | BEAVER VISITEC INTERNATIONAL, INC. |
| Manufacturer Street | 500 TOTTEN POND RD 10 CITYPOINT |
| Manufacturer City | WALTHAM, MA |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-501-2018 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BEAVER? AND EDGEAHEAD SAFETY SIDEPORT MVR KNIFE, 1.15 MM, 45 DEGREES (20G) |
| Generic Name | BEAVER? AND EDGEAHEAD SAFETY SIDEPORT MVR KNIFE, 1.15 MM, 45 DEGREES (20G) |
| Product Code | HNN |
| Date Received | 2020-03-28 |
| Returned To Mfg | 2019-05-08 |
| Catalog Number | 378231 |
| Lot Number | 6010668 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEAVER VISITEC INTERNATIONAL, INC |
| Manufacturer Address | 500 TOTTEN POND RD 10 CITYPOINT WALTHAM, MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-28 |