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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PRLNE HERNIA SYSTEM MSH 7.5CM UNDERLAY MESH, SURGICAL, POLYMERIC

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ETHICON INC. PRLNE HERNIA SYSTEM MSH 7.5CM UNDERLAY MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PHSM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Nerve Damage (1979)
Event Type  Injury  
Event Description
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2019 and mesh was implanted. It was reported that the patient underwent removal surgery, right inguinal exploration, ilioinguinal nerve lysis, neurolysis of peripheral nerve and excision of lipoma on (b)(6) 2019 during which the surgeon noted it took sharp, blunt dissection to remove the external oblique from attachment to the mesh, noting a good amount of ingrowth, the contents of the spermatic cord were encircled which he then dissected free, stating that the mesh was well incorporated into the inguinal ring and to remove completely would do more harm than good, he took off redundant mesh which was lateral to the abdominal wall in inguinal floor and removed the ilioinguinal nerve. It was reported that the patient experienced an unknown adverse event. No additional information was provided.
 
Manufacturer Narrative
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.
 
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Brand NamePRLNE HERNIA SYSTEM MSH 7.5CM UNDERLAY
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
J-PAC
25 centre road
somersworth NH 03878
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key14708847
MDR Text Key294934041
Report Number2210968-2022-04585
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10705031048997
UDI-Public10705031048997
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 06/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2022
Device Model NumberPHSM
Device Catalogue NumberPHSM
Device Lot Number31249J01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2017
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: 06/15/2022 Patient Sequence Number: 1
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