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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 PHSL
Device Problem Migration (4003)
Patient Problems Adhesion(s) (1695); Ecchymosis (1818); Nerve Damage (1979); Pain (1994); Hernia (2240); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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.
 
Event Description
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2010 and mesh was implanted. It was reported that the patient underwent recurrent hernia repair surgery with removal of part of the mesh on (b)(6) 2012 during which the surgeon noted the internal portion of the mesh system was encountered and found to be balled up medially along the epigastric vessels and adherent to an area of cooper ligament. There was an indirect hernia noted on the lateral aspect of the ring. It was reported that the patient experienced pain, tenderness, swelling, ecchymosis, adhesions, nerve damage, entrapment and mesh migration. No additional information was provided.
 
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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 08869
Manufacturer (Section G)
J-PAC
25 centre road
somersworth NH 03878
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key13657245
MDR Text Key287343046
Report Number2210968-2022-01351
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10705031048966
UDI-Public10705031048966
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
Report Date 03/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPHSL
Device Catalogue NumberPHSL
Was Device Available for Evaluation? No
Date Manufacturer Received02/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/02/2022 Patient Sequence Number: 1
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