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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 PHSL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); 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 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) 2012 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2014.It was reported that the patient experienced severe and chronic pain, inflammation and lipoma.No additional information is provided.
 
Manufacturer Narrative
Date sent to fda: 10/27/2020 additional information: d4 a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
Manufacturer Narrative
Date sent to the fda: (b)(6) 2021.Additional information: a1, a2, b7, d3.
 
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Brand Name
PRLNE HERNIA SYSTEM MSH 10CM UNDERLAY
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08876
MDR Report Key10619188
MDR Text Key209562010
Report Number2210968-2020-07563
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10705031048966
UDI-Public10705031048966
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,Followup,Followup
Report Date 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/31/2017
Device Model NumberPHSL
Device Catalogue NumberPHSL6
Device Lot Number24935-01
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/29/2020
Initial Date FDA Received10/02/2020
Supplement Dates Manufacturer Received10/26/2020
06/07/2021
Supplement Dates FDA Received10/27/2020
06/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 YR
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