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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PRLNE HERNIA SYSTEM MSH 10CM UNDERLAY MESH, SURGICAL, POLYMERIC

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ETHICON INC. PRLNE HERNIA SYSTEM MSH 10CM UNDERLAY MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PHSE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pain (1994); Not Applicable (3189)
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. Mwr-17122018-0000277351 submitted for adverse event which occurred on (b)(6) 2007.   mwr-17122018-0000277352 submitted for adverse event which occurred on (b)(6) 2018.   mwr-17122018-0000277353 submitted for adverse event which occurred on (b)(6) 2018.   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 inguinal hernia repair surgery on (b)(6) 2007 and mesh was implanted. It was reported that the patient underwent a right groin exploration and excision of scar on (b)(6) 2007 during which granulation tissue was noted in the area, which was excised, including a portion of the mesh. It was reported that the patient underwent additional mesh revision surgeries on (b)(6) 2018 and (b)(6) 2018. It was reported that the patient experienced severe pain and increasing inflammation. No additional information is provided.
 
Manufacturer Narrative
Date sent to the fda: 12/9/2021.
 
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Brand NamePRLNE HERNIA SYSTEM MSH 10CM UNDERLAY
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08876 0151
Manufacturer (Section G)
J-PAC
25 centre road
somersworth NH 03878 0151
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8198967
MDR Text Key131482644
Report Number2210968-2018-77802
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2011
Device Model NumberPHSE
Device Catalogue NumberPHSE
Device Lot Number15940-07
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/27/2007
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: 12/27/2018 Patient Sequence Number: 1
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