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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
Catalog Number PHSM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); 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 info derived from the evaluation will be submitted in a supplemental 3500a form. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
Event Description
It was reported by an attorney that the patient underwent inguinal hernia repair surgery on (b)(6) 2014 and mesh was implanted. It was reported that the patient had removal surgery on (b)(6) 2014 during which the surgeon noted ¿a hard mass just beneath the external oblique fascia. The mass was the posterior portion of the mesh which had balled up. ¿ it was reported that the patient experienced pain. No additional information is 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 0151
Manufacturer (Section G)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8203299
MDR Text Key131636413
Report Number2210968-2018-78059
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10705031048997
UDI-Public10705031048997
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K984220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 11/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2018
Device Catalogue NumberPHSM
Device Lot Number26713-11
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/10/2013
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: 12/28/2018 Patient Sequence Number: 1
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