MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-09-04 for ANTERIOR CHAMBER CANNULA (RYCROFT), .30X22MM (30 G X 7/8 IN) 581273 manufactured by Beaver Visitec International, Inc.
| Report Number | 1211998-2019-00002 |
| MDR Report Key | 8962539 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-09-04 |
| Date of Report | 2019-05-17 |
| Date of Event | 2019-05-01 |
| Date Mfgr Received | 2019-05-17 |
| Device Manufacturer Date | 2018-10-30 |
| Date Added to Maude | 2019-09-04 |
| 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. GENCI OMARI |
| Manufacturer Street | 500 TOTTEN POND RD - 10 CITYPOINT |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7819066925 |
| Manufacturer G1 | BEAVER-VISITEC INTERNATIONAL, INC |
| Manufacturer Street | 500 TOTTEN POND RD 10 CITYPOINT |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02451 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANTERIOR CHAMBER CANNULA (RYCROFT), .30X22MM (30 G X 7/8 IN) |
| Generic Name | ANTERIOR CHAMBER CANNULA [RYCROFT] 30 X 22 MM (30G X 7/8 IN) |
| Product Code | HMX |
| Date Received | 2019-09-04 |
| Returned To Mfg | 2019-08-12 |
| Catalog Number | 581273 |
| Lot Number | 6007871 |
| 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 02451 US 02451 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-04 |