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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-17 for * manufactured by *.

Event Text Entries

[19690739] Occuloplasty pack plain sponge had debris.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2792377
• MDR Report Key: 2792377
• Date Received: 2012-09-17
• Date of Report: 2012-09-17
• Date of Event: 2012-09-04
• Report Date: 2012-09-17
• Date Reported to FDA: 2012-09-17
• Date Added to Maude: 2012-10-16
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• 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
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: SURGICAL PACK, CUSTOM, OCCULOPLAST
• Product Code: OJK
• Date Received: 2012-09-17
• Model Number: *
• Catalog Number: *
• Lot Number: 855712
• ID Number: *
• Device Availability: *
• Device Age: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: *
• Manufacturer Address: * * * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-09-17