STLESS STEEL SIL 4X18IN 5 S/A CCS M653G

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-09-25 for STLESS STEEL SIL 4X18IN 5 S/A CCS M653G manufactured by Ethicon Inc..

MAUDE Entry Details

• Report Number: 2210968-2019-88070
• MDR Report Key: 9115713
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-09-25
• Date of Report: 2019-08-29
• Date of Event: 2019-07-28
• Date Mfgr Received: 2019-10-07
• Device Manufacturer Date: 2019-02-18
• Date Added to Maude: 2019-09-25
• 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: 3
• Manufacturer Contact: DARLENE KYLE
• Manufacturer Street: P.O. BOX 151, ROUTE 22 WEST
• Manufacturer City: SOMERVILLE NJ 088760151
• Manufacturer Country: US
• Manufacturer Postal: 088760151
• Manufacturer Phone: 9082182792
• Manufacturer G1: ETHICON INC.-BRAZIL
• Manufacturer Street: RODOVIA PRESIDENTE DUTRA KM 154
• Manufacturer City: SAO PAOLO 12240-908
• Manufacturer Country: BR
• Manufacturer Postal Code: 12240-908
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STLESS STEEL SIL 4X18IN 5 S/A CCS
• Generic Name: SUTURE, NONABSORBABLE, STEEL
• Product Code: GAQ
• Date Received: 2019-09-25
• Catalog Number: M653G
• Lot Number: AL7975
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ETHICON INC.
• Manufacturer Address: P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 088760151 US 088760151

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-09-25