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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 Nerve Damage (1979); Pain (1994); Hernia (2240)
Event Type  Injury  
Event Description
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2015 and mesh was implanted.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2021 during which the surgeon noted he encountered, detached and removed the mesh from the transversus abdominis and iliopubic tract.He noted that he did not think it was in his best interest to remove additional mesh at that point.It was reported that the patient experienced severe pain, nerve damage, stress and anxiety.No additional information was provided.
 
Manufacturer Narrative
Date sent to the fda: 4/3/2022.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.
 
Manufacturer Narrative
Date sent to the fda: 4/11/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
Manufacturer Narrative
Date sent to the fda: 09/14/2022.
 
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Brand Name
PRLNE HERNIA SYSTEM MSH 10CM UNDERLAY
Type of Device
MESH, 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 Key13992624
MDR Text Key293162165
Report Number2210968-2022-02343
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10705031048935
UDI-Public10705031048935
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 Other
Type of Report Initial,Followup,Followup
Report Date 04/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/31/2020
Device Model NumberPHSE
Device Catalogue NumberPHSE
Device Lot Number28997J13
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received09/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/10/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
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