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ETHICON INC. PHY2535V MESH, SURGICAL Back to Search Results
Catalog Number PHY2535V
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Pain (1994); Injury (2348); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative

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.

Event Description

It was reported by an attorney that the patient underwent a hernia repair procedure on (b)(6) 2016 and mesh was implanted. It was reported the patient experienced an undisclosed adverse event. It was reported that the patient underwent a previous hernia repair procedure on (b)(6) 2016 and mesh was implanted. Other procedure is captured in separate file. No additional information was provided.

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Brand NamePHY2535V
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
MDR Report Key9756514
MDR Text Key186759979
Report Number2210968-2020-01504
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK093932
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/25/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/26/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Catalogue NumberPHY2535V
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial