MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-02-07 for OPMI VARIO 700 N/A 302570-9002-000 manufactured by Carl Zeiss Meditec Ag (oberkochen).
Report Number | 9615010-2020-00002 |
MDR Report Key | 9684665 |
Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
Date Received | 2020-02-07 |
Date of Report | 2020-01-09 |
Date of Event | 2020-01-09 |
Date Mfgr Received | 2020-01-09 |
Device Manufacturer Date | 2017-01-31 |
Date Added to Maude | 2020-02-07 |
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 VERNON BROWN |
Manufacturer Street | 5160 HACIENDA DRIVE |
Manufacturer City | DUBLIN CA 94568 |
Manufacturer Country | US |
Manufacturer Postal | 94568 |
Manufacturer Phone | 9255574616 |
Manufacturer G1 | CARL ZEISS MEDITEC AG (OBERKOCHEN) |
Manufacturer Street | RUDOLF-EBER-STRASSE 11 |
Manufacturer City | OBERKOCHEN, 73447 |
Manufacturer Country | GM |
Manufacturer Postal Code | 73447 |
Single Use | 3 |
Previous Use Code | 3 |
Removal Correction Number | N/A |
Event Type | 3 |
Type of Report | 3 |
Brand Name | OPMI VARIO 700 |
Generic Name | MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY |
Product Code | FSO |
Date Received | 2020-02-07 |
Model Number | N/A |
Catalog Number | 302570-9002-000 |
Lot Number | N/A |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | CARL ZEISS MEDITEC AG (OBERKOCHEN) |
Manufacturer Address | RUDOLF-EBER-STRASSE 11 OBERKOCHEN, 73447 GM 73447 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-02-07 |