* SB103242

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-10-16 for * SB103242 manufactured by Cook Surgical.

Event Text Entries

[268111] Pt received an abdominal infection from the intestinal graft.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1026457
• MDR Report Key: 422748
• Date Received: 2002-10-16
• Date of Report: 2002-09-01
• Date of Event: 2002-04-05
• Date Added to Maude: 2002-10-22
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: INTESTINAL GRAPH
• Product Code: LNN
• Date Received: 2002-10-16
• Model Number: *
• Catalog Number: SB103242
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 411801
• Manufacturer: COOK SURGICAL
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2002-10-16