UROPATCH *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-09-29 for UROPATCH * manufactured by Classic Medical Inc..

Event Text Entries

[162345] Add'l info received from mfr on 11/19/99: this product is not mfg by classic medical, inc. Co has forwarded all correspondence to the mfr, and is informed they will respond directly.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4002617
• MDR Report Key: 244342
• Date Received: 1999-09-29
• Date of Report: 1999-09-21
• Date of Event: 1999-09-13
• Date Added to Maude: 1999-10-14
• 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
• 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: UROPATCH
• Generic Name: BOVINE PERICARDIAL GRAFT
• Product Code: MFX
• Date Received: 1999-09-29
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 236720
• Manufacturer: CLASSIC MEDICAL INC.
• Manufacturer Address: 2745 E. ATLANTIC BLVD. SUITE 302 POMPANO BEACH FL 33062 US
• Baseline Brand Name: UROPATCH-PERICARDIAL PATCH
• Baseline Generic Name: BOVINE PUBO-VAGINAL SLING.
• Baseline Model No: SHP555-2X7 ORT
• Baseline Catalog No: *
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0		1999-09-29