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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PHY1020V MESH, SURGICAL

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ETHICON INC. PHY1020V MESH, SURGICAL Back to Search Results
Catalog Number PHY1020V
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Fistula (1862); Injury (2348); Post Operative Wound Infection (2446); Not Applicable (3189)
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) 2015 and mesh was implanted. It was reported the patient experienced an undisclosed adverse event. No additional information was provided.

 
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Brand NamePHY1020V
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-GMBH
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key9853176
MDR Text Key184081363
Report Number2210968-2020-02204
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
Report Date 03/18/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/19/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2017
Device Catalogue NumberPHY1020V
Device LOT NumberJH8GBTC0
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 Received08/25/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/21/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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