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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 PHSE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Hernia (2240)
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) 2014 and mesh was implanted. It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2020 during which the surgeon noted a huge recurrent hernia and the mesh was completely stuck to the hernia sac as well as the incarcerated colon. He tried to cut out some of the mesh but experienced difficulty at first because part of the bowel was stuck. He ultimately removed the mesh as much as possible. It was reported that the patient experienced severe pain. No additional information was provided.
 
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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
MDR Report Key12717206
MDR Text Key282570986
Report Number2210968-2021-10574
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K180829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 10/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPHSE
Device Catalogue NumberPHSE
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/29/2021 Patient Sequence Number: 1
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