VISCERA RETAINER 3201

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2004-08-19 for VISCERA RETAINER 3201 manufactured by Adept-med Intl., Inc..

Event Text Entries

[355662] In 2004 received telephone call from laboratory conducting product testing which drew the sterility of the product into question.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2918699-2004-00003
• MDR Report Key: 540067
• Report Source: 00
• Date Received: 2004-08-19
• Date of Report: 2004-08-19
• Date of Event: 2004-08-13
• Date Mfgr Received: 2004-08-13
• Device Manufacturer Date: 2004-02-01
• Date Added to Maude: 2004-08-23
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 0
• Manufacturer Street: 665 PLEASANT VALLET RD.
• Manufacturer City: DIAMOND SPRINGS CA 95619
• Manufacturer Country: US
• Manufacturer Postal: 95619
• Manufacturer Phone: 9499533110
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: RC
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VISCERA RETAINER
• Generic Name: VISCERA RETAINER
• Product Code: GCZ
• Date Received: 2004-08-19
• Model Number: 3201
• Catalog Number: 3201
• Lot Number: 11503
• ID Number: NA
• Device Expiration Date: 2005-11-30
• Operator: OTHER
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 529376
• Manufacturer: ADEPT-MED INTL., INC.
• Manufacturer Address: * DIAMOND SPRINGS CA 95619 US
• Baseline Brand Name: VISCERA RETAINER
• Baseline Generic Name: VISCERA RETAINER
• Baseline Model No: 3201
• Baseline Catalog No: 3201
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2004-08-19