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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 Problems Pain (1994); Hernia (2240); Numbness (2415)
Event Type  Injury  
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.
 
Event Description
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2011 and mesh was implanted. It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2015 during which the surgeon noted she encountered the old mesh, which she spent the better part of an hour dissecting from the external oblique, internal oblique and from the cord structures. It was reported that the patient experienced severe pain, numbness, tingling sensation, impaired sexual relations, mesh dissection, stress and anxiety. No additional information was provided.
 
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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
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12492229
MDR Text Key273079328
Report Number2210968-2021-08626
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 08/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2016
Device Model NumberPHSM
Device Catalogue NumberPHSM
Device Lot Number23621-05
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/19/2011
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: 09/17/2021 Patient Sequence Number: 1
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