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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE* POLY HERNIA MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHSL
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Fatigue (1849); Pain (1994); No Code Available (3191)
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. In addition, a device history review has been inserted into the file. This review indicates that there was no quality concerns associated with the manufacturing process.
 
Event Description
It was reported by an attorney that the patient underwent a hernia repair surgery on 12/19/2013 and mesh was implanted. It was reported that the patient experienced an undisclosed adverse event. It was reported that the patient continues to experience pain, aching, ¿brain fog¿ and fatigue. No additional information was provided.
 
Manufacturer Narrative
Date sent to fda: 7/27/2018 additional information:.
 
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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
Manufacturer (Section G)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7362776
MDR Text Key103218351
Report Number2210968-2018-71223
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K984220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2018
Device Catalogue NumberPHSL
Device Lot Number26711-15
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 Received07/16/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/18/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/22/2018 Patient Sequence Number: 1
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