MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-20 for CRYO PROBE: EXTENDED RETINAL, 2.5 MM 1540.D manufactured by D.o.r.c. Dutch Ophthalmic Research Center (interna.
Report Number | 1222074-2019-00028 |
MDR Report Key | 9097217 |
Date Received | 2019-09-20 |
Date Added to Maude | 2019-09-20 |
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 | CRYO PROBE: EXTENDED RETINAL, 2.5 MM |
Generic Name | DISPOSABLE CRYOPROBES |
Product Code | HRN |
Date Received | 2019-09-20 |
Catalog Number | 1540.D |
Lot Number | 2000403371 |
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 | 2019-09-20 |