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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE* POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE* POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PMII
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative
(b)(4). To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. Ethicon mdr summary reporting exemption (b)(4). Reporting period october 1, 2018 through november 30, 2018. (b)(4). Total number of events ¿ 32. Proceed multi-layer mesh - 0. Prolene polypropylene mesh - 26. Prolene soft polypropylene mesh - 5. Ultrapro mesh - 0. Vicryl polyglactin 910 mesh ¿ 1.
 
Event Description
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2010 and the mesh was implanted. Following the procedure, the patient experienced undisclosed injuries. No further information is available.
 
Manufacturer Narrative
Ethicon mdr summary reporting exemption e2013037. Reporting period october 1, 2018 through november 30, 2018.
 
Manufacturer Narrative
Date sent to fda: 4/24/2019. Ethicon mdr summary reporting exemption e2013037. Reporting period october 1, 2018 through november 30, 2018.
 
Manufacturer Narrative
Date sent to fda: 10/22/2020. Ethicon mdr summary reporting exemption e2013037. Reporting period october 1, 2018 through november 30, 2018.
 
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Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key8202919
MDR Text Key131619095
Report Number2210968-2018-78063
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K180829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial,Followup,Followup,Followup
Report Date 09/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2014
Device Model NumberPMII
Device Catalogue NumberPMII
Device Lot NumberBGP687
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/22/2020
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 12/28/2018 Patient Sequence Number: 1
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