OPMI LUMERA N/A 000000-1087-851

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-04 for OPMI LUMERA N/A 000000-1087-851 manufactured by Carl Zeiss Meditec Ag (oberkochen).

MAUDE Entry Details

• Report Number: 9615010-2019-00013
• MDR Report Key: 9158714
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-10-04
• Date of Report: 2019-09-05
• Date of Event: 2019-08-30
• Date Mfgr Received: 2019-09-05
• Device Manufacturer Date: 2008-12-10
• Date Added to Maude: 2019-10-04
• 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. 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

Device Details

• Brand Name: OPMI LUMERA
• Generic Name: OPMI LUMERA
• Product Code: HRM
• Date Received: 2019-10-04
• Model Number: N/A
• Catalog Number: 000000-1087-851
• 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

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-10-04