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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 Appropriate Term/Code Not Available (3191)
Patient Problems Injury (2348); Not Applicable (3189)
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. (b)(4) submitted for adverse event which occurred on (b)(6) 2009. (b)(4) submitted for adverse event which occurred on (b)(6) 2017.

 
Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2005 and mesh was implanted. It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2009 and mesh was implanted during which the surgeon noted evidence of old mesh. There was a wad of mesh at the internal ring. There was also mesh along the patient¿s inguinal canal and including the external oblique. Once the mesh was removed, the vas deferens of the spermatic cord was noted. There was evidence of a weakness in the floor consistent with a direct hernia. It was reported that the patient underwent right inguinal hernia repair surgery on (b)(6) 2017 and mesh was implanted. It was reported that the patient experienced an unknown event. Other procedure is captured in a separate file. 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.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
J-PAC
25 centre road
somersworth NH
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10837047
MDR Text Key216189304
Report Number2210968-2020-09024
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK180829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/11/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2009
Device MODEL NumberPHSM
Device Catalogue NumberPHSM
Device LOT NumberJBF4029M
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 Received11/22/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/20/2004
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/13/2020 Patient Sequence Number: 1
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