GUT PL UD 27IN 2-0 S/A CT 853H

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-27 for GUT PL UD 27IN 2-0 S/A CT 853H manufactured by Ethicon Inc..

MAUDE Entry Details

• Report Number: 2210968-2020-01590
• MDR Report Key: 9765993
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2020-02-27
• Date of Report: 2020-02-03
• Date of Event: 2020-02-03
• Date Mfgr Received: 2020-02-03
• Device Manufacturer Date: 2019-06-26
• Date Added to Maude: 2020-02-27
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: KARA DITTY-BOVARD
• Manufacturer Street: P.O. BOX 151, ROUTE 22 WEST
• Manufacturer City: SOMERVILLE NJ 08876
• Manufacturer Country: US
• Manufacturer Postal: 08876
• Manufacturer Phone: 6107428552
• Manufacturer G1: ETHICON INC.-JUAREZ
• Manufacturer Street: AVENIDA DE LAS TORRES 7125 COL SALVACAR
• Manufacturer City: CIUDAD JUAREZ 32604
• Manufacturer Country: MX
• Manufacturer Postal Code: 32604
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: GUT PL UD 27IN 2-0 S/A CT
• Generic Name: SUTURE, ABSORBABLE, NATURAL
• Product Code: GAL
• Date Received: 2020-02-27
• Returned To Mfg: 2020-02-19
• Model Number: 853H
• Catalog Number: 853H
• Lot Number: PGK766
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ETHICON INC.
• Manufacturer Address: P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-27