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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); Hemorrhage/Bleeding (1888); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
(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.
Event Description
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2012 and mesh was implanted. It was reported the patient experienced an unknown event. No additional information was provided.
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Brand NamePHY2535V
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
1000 route 202
raritan NJ 08876
Manufacturer (Section G)
p.o. box 1409
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
MDR Report Key11490480
MDR Text Key242898179
Report Number2210968-2021-02355
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2013
Device Catalogue NumberPHY2535V
Device Lot NumberDH8KHBA0
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 Received07/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/25/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/15/2021 Patient Sequence Number: 1