ETHICON, INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT MPH256

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-10 for ETHICON, INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT MPH256 manufactured by Ethicon, Inc..

MAUDE Entry Details

• Report Number: MW5089707
• MDR Report Key: 8992361
• Date Received: 2019-09-10
• Date of Report: 2019-09-08
• Date of Event: 2019-04-03
• Date Added to Maude: 2019-09-11
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• 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
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: ETHICON, INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT
• Generic Name: CUTANEOUS TISSUE ADHESIVE WITH MESH
• Product Code: OMD
• Date Received: 2019-09-10
• Catalog Number: MPH256
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ETHICON, INC.
• Manufacturer Address: SOMERVILLE NJ 08876 US 08876

Device Sequence Number: 2

• Brand Name: ETHICON, INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT
• Generic Name: CUTANEOUS TISSUE ADHESIVE WITH MESH
• Product Code: OMD
• Date Received: 2019-09-10
• Catalog Number: MPH056
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: ETHICON, INC.
• Manufacturer Address: SOMERVILLE NJ 08876 US 08876

Device Sequence Number: 3

• Brand Name: ETHICON, INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT
• Generic Name: CUTANEOUS TISSUE ADHESIVE WITH MESH
• Product Code: OMD
• Date Received: 2019-09-10
• Catalog Number: MMJ779
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: ETHICON, INC.
• Manufacturer Address: SOMERVILLE NJ 08876 US 08876

Device Sequence Number: 4

• Brand Name: ETHICON, INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT
• Generic Name: CUTANEOUS TISSUE ADHESIVE WITH MESH
• Product Code: OMD
• Date Received: 2019-09-10
• Catalog Number: MPH208
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: ETHICON, INC.
• Manufacturer Address: SOMERVILLE NJ 08876 US 08876

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-09-10