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 NumberMW5089716
MDR Report Key8992625
Date Received2019-09-10
Date of Report2019-09-08
Date of Event2019-05-14
Date Added to Maude2019-09-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameETHICON, INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT
Generic NameCUTANEOUS TISSUE ADHESIVE WITH MESH
Product CodeOMD
Date Received2019-09-10
Catalog NumberMPH256
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerETHICON, INC.
Manufacturer AddressSOMERVILLE NJ 08876 US 08876

Device Sequence Number: 2

Brand NameETHICON, INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT
Generic NameCUTANEOUS TISSUE ADHESIVE WITH MESH
Product CodeOMD
Date Received2019-09-10
Catalog NumberMPH056
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerETHICON, INC.
Manufacturer AddressSOMERVILLE NJ 08876 US 08876

Device Sequence Number: 3

Brand NameETHICON, INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT
Generic NameCUTANEOUS TISSUE ADHESIVE WITH MESH
Product CodeOMD
Date Received2019-09-10
Catalog NumberMMJ779
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No3
Device Event Key0
ManufacturerETHICON, INC.
Manufacturer AddressSOMERVILLE NJ 08876 US 08876

Device Sequence Number: 4

Brand NameETHICON, INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT
Generic NameCUTANEOUS TISSUE ADHESIVE WITH MESH
Product CodeOMD
Date Received2019-09-10
Catalog NumberMPH208
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No4
Device Event Key0
ManufacturerETHICON, INC.
Manufacturer AddressSOMERVILLE NJ 08876 US 08876


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-10

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