DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE CLR222

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 2019-09-11 for DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE CLR222 manufactured by Ethicon Inc..

MAUDE Entry Details

• Report Number: 2210968-2019-87045
• MDR Report Key: 8995145
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-09-11
• Date of Report: 2019-08-15
• Date of Event: 2019-08-15
• Date Mfgr Received: 2019-09-27
• Device Manufacturer Date: 2018-10-30
• Date Added to Maude: 2019-09-11
• 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 088760151
• Manufacturer Country: US
• Manufacturer Postal: 088760151
• Manufacturer Phone: 6107428552
• Manufacturer G1: ETHICON INC.-SAN LORENZO PR
• Manufacturer Street: ROAD 183, KM. 8.3
• Manufacturer City: SAN LORENZO 00754
• Manufacturer Postal Code: 00754
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
• Generic Name: SURGICAL SEALANT
• Product Code: OMD
• Date Received: 2019-09-11
• Returned To Mfg: 2019-09-27
• Catalog Number: CLR222
• Lot Number: MLA146
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• 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 088760151 US 088760151

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-09-11