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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH 15X15CM MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE MESH 15X15CM MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PMM3
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/20/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. Evaluation: pictures were received for evaluation and the following was observed: upon visual inspection of picture 3 the image shows a box with product code, lot number and expiration date not visible. The packaging qr was scanned, and the information was obtained. The lot number obtained from the qr codes, was entered in our system and the lot number, manufacture date, and expiration date was found with the product code belonging to another product. The discrepancy in the qr code on the package of image 3, where it belongs to another product code, concludes that this is a confirmed counterfeit. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. 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 an ethicon product was suspected to be a counterfeit device on (b)(6) 2020 and the mesh was involved. Upon evaluation of the returned photo the device was confirmed to be a counterfeit. There was no patient involvement reported.
 
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Brand NamePROLENE MESH 15X15CM
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.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo 00754
00754
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10693182
MDR Text Key211935467
Report Number2210968-2020-08089
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodePK
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 09/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMM3
Device Lot NumberLHE994
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/12/2017
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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