FDA Adverse Event Other Summary report: N

GENTIAN MARKING PAD

MDR report key: 494627 · Received September 11, 2003

Report

Report Number
1211998-2003-00003
Event Type
Other
Date Received
September 11, 2003
Manufacturer
BD OPHTHALMIC SYSTEMS
Product Code
HMQ
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CA
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE ACCOUNT THINKS THE MARKING PADS CUASED DLK IN 7 CASES IN 8/2003.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 GENTIAN MARKING PAD BD VISIMARK VIOLET MARKING PAD HMQ BD OPHTHALMIC SYSTEMS * 3155268

Patients

Seq Age Sex Outcome Treatment
1 * Other