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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 Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Hematoma (1884); Nerve Damage (1979); Seroma (2069); Hernia (2240); 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) 2011 and mesh was implanted. It was reported that the patient underwent removal surgery and inguinal hernia repair surgery on (b)(6) 2013 and mesh was implanted during which the surgeon noted the mesh was found to be wrapped completely around the cord structures. The inguinal canal floor was disrupted. It was reported that the patient experienced an unknown adverse event. Other procedure is captured under 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.
1000 route 202
raritan 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
9082182213
MDR Report Key11437319
MDR Text Key238875645
Report Number2210968-2021-02097
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,Followup
Report Date 03/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2016
Device Model NumberPHSM
Device Catalogue NumberPHSM
Device Lot Number23625-03
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 Received09/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/14/2012
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: 03/08/2021 Patient Sequence Number: 1
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