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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems 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) 2014 and mesh was implanted. It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2020 during which the surgeon noted ¿the mesh to have pulled away from the pubic tubercle. ¿ it was reported that the patient experienced severe pain, stress and anxiety. No additional information was provided.
 
Manufacturer Narrative
Date sent to the fda: 12/27/2021. 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 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
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key13090770
MDR Text Key286755679
Report Number2210968-2021-12996
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 12/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2019
Device Model NumberPHSL
Device Catalogue NumberPHSL
Device Lot Number28379-03
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/08/2014
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: 12/27/2021 Patient Sequence Number: 1
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