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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO PLUG MESHES MESH, SURGICAL, POLYMERIC

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ETHICON INC. ULTRAPRO PLUG MESHES MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number UPPM1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Foreign Body Reaction (1868)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative

Product complaint # (b)(4). A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.   attempts are being made to obtain the following information.   to date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Was medical intervention required to treat the patient condition? results. Were antibiotics prescribed? does the surgeon believe there was any deficiency with the ethicon product involved? what is the patient¿s current status?   if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

 
Event Description

It was reported that a patient underwent a hernia repair procedure on an unknown date and the mesh was implanted. It was reported that the patient received the device 10 years ago and is having issues. It was also reported that the surgeon suspects immunological reaction to the product.

 
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Brand NameULTRAPRO PLUG MESHES
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082182213
MDR Report Key11579955
MDR Text Key242716796
Report Number2210968-2021-02820
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK070224
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 02/26/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/27/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2012
Device Catalogue NumberUPPM1
Device LOT NumberCC8PSQA0
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/29/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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