ETHILON BLK 45CM M0.7::USP6/0 SGLE ARMED PS-3 PRIM MP XAMPE7662H

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-13 for ETHILON BLK 45CM M0.7::USP6/0 SGLE ARMED PS-3 PRIM MP XAMPE7662H manufactured by Ethicon Inc..

MAUDE Entry Details

• Report Number: 2210968-2020-02024
• MDR Report Key: 9829491
• Report Source: FOREIGN,HEALTH PROFESSIONAL
• Date Received: 2020-03-13
• Date of Report: 2020-02-19
• Date of Event: 2020-01-01
• Date Mfgr Received: 2020-02-19
• Device Manufacturer Date: 2019-05-02
• Date Added to Maude: 2020-03-13
• 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: 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.-SAN LORENZO PR
• Manufacturer Street: ROAD 183, KM. 8.3
• Manufacturer City: SAN LORENZO 00754
• Manufacturer Country: *
• Manufacturer Postal Code: 00754
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ETHILON BLK 45CM M0.7::USP6/0 SGLE ARMED PS-3 PRIM MP
• Generic Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Product Code: GAR
• Date Received: 2020-03-13
• Returned To Mfg: 2020-03-11
• Catalog Number: XAMPE7662H
• Lot Number: PEB903
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: N
• 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		2020-03-13