ALLO SOURCE/UROMED CORP. 120270 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-03-17 for ALLO SOURCE/UROMED CORP. 120270 * manufactured by Allo Source/uromed Corp..

Event Text Entries

[18329006] Allo source; allo sling fascia; product code 120270. Fascia lata w2 x l15 cm; fascia lata not size stated (too small).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 215107
• MDR Report Key: 215107
• Date Received: 1999-03-17
• Date of Report: 1999-03-15
• Date of Event: 1999-03-12
• Date Facility Aware: 1999-03-12
• Report Date: 1999-03-15
• Date Reported to FDA: 1999-03-15
• Date Reported to Mfgr: 1999-03-15
• Date Added to Maude: 1999-03-23
• 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
• Reporter Occupation: RISK MANAGER
• 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: ALLO SOURCE/UROMED CORP.
• Generic Name: FASCIA LATA
• Product Code: MNG
• Date Received: 1999-03-17
• Model Number: 120270
• Catalog Number: *
• Lot Number: *
• ID Number: ID 980691005
• Device Expiration Date: 2003-09-17
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 208663
• Manufacturer: ALLO SOURCE/UROMED CORP.
• Manufacturer Address: 8085 E HARVARD AVE DENVER CO 80231 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-03-17