MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-30 for BACKFLUSH INSTRUMENT WITH 25 GA / 0.5 MM SOFT-TIP CANNULA AND ACTIVE ASPIRATION 2281.STD05 manufactured by D.o.r.c. Dutch Ophthalmic Research Center (interna.
| Report Number | 1222074-2019-00024 |
| MDR Report Key | 8951301 |
| Date Received | 2019-08-30 |
| Date Added to Maude | 2019-08-30 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CHRIS FRYER |
| Manufacturer Street | SCHEIJDELVEQEG 2 |
| Manufacturer City | ZUILAND, 3214VN |
| Manufacturer Country | NL |
| Manufacturer Postal | 3214 VN |
| Manufacturer G1 | D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA |
| Manufacturer Street | SCHEIJDELVEQEG 2 |
| Manufacturer City | ZUILAND, 3214VN |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 3214 VN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACKFLUSH INSTRUMENT WITH 25 GA / 0.5 MM SOFT-TIP CANNULA AND ACTIVE ASPIRATION |
| Generic Name | VITRECTOMY FLUID / GAS HANDLING INSTRUMENT |
| Product Code | HMX |
| Date Received | 2019-08-30 |
| Catalog Number | 2281.STD05 |
| Lot Number | 2000392357 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER (INTERNA |
| Manufacturer Address | SCHEIJDELVEQEG 2 ZUILAND, 3214VN NL 3214 VN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-30 |