PROCEED*SURG MESH/MULTI LYR PCDN1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-31 for PROCEED*SURG MESH/MULTI LYR PCDN1 manufactured by Ethicon Inc..

Event Text Entries

[186697868] (b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Patient Sequence No: 1, Text Type: N, H10


[186697869] It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2016 and mesh was implanted. It was reported that the patient underwent recurrent ventral hernia repair surgery on (b)(6) 2018. It was reported that the patient experienced adhesions, devitalized tissue, deformed umbilicus and intractable abdominal pain and nausea. No additional information is provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2020-02448
MDR Report Key9904745
Report SourceOTHER
Date Received2020-03-31
Date of Report2020-03-30
Date Mfgr Received2020-03-26
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer StreetP.O. BOX 151, ROUTE 22 WEST
Manufacturer CitySOMERVILLE NJ 08876
Manufacturer CountryUS
Manufacturer Postal08876
Manufacturer Phone6107428552
Manufacturer G1ETHICON INC.-CORNELIA
Manufacturer Street655 ETHICON CIRCLE
Manufacturer CityCORNELIA GA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROCEED*SURG MESH/MULTI LYR
Generic NameMESH, SURGICAL, POLYMERIC
Product CodeFTL
Date Received2020-03-31
Catalog NumberPCDN1
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerETHICON INC.
Manufacturer AddressP.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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