DISPOSABLE LAP INVENTORY NUMBER 29816 REF. LDIII

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-31 for DISPOSABLE LAP INVENTORY NUMBER 29816 REF. LDIII manufactured by Unk.

Event Text Entries

[384490] Disposable lap sponge ripped into 2 pieces while in abdomen. Both pieces were removed and sequestered.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 566176
• MDR Report Key: 566176
• Date Received: 2004-12-31
• Date of Report: 2004-12-31
• Date of Event: 2004-09-21
• Report Date: 2004-12-31
• Date Reported to FDA: 2004-12-31
• Date Added to Maude: 2005-01-20
• 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: 0
• 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: DISPOSABLE LAP
• Generic Name: LAPAROTOMY SPONGE
• Product Code: FHI
• Date Received: 2004-12-31
• Model Number: INVENTORY NUMBER 29816
• Catalog Number: REF. LDIII
• Lot Number: 040130
• ID Number: *
• Device Availability: Y
• Device Age: 1 DY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 555962
• Manufacturer: UNK
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-12-31