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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROCEED*SURG MESH/MULTI LYR; MESH, SURGICAL, POLYMERIC
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ETHICON INC. PROCEED*SURG MESH/MULTI LYR; MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PCDN1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Hernia (2240)
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) 2014 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2015.It was reported that the patient experienced mesh migration, infections, chronic pain and swelling abdomen.No additional information is provided.
 
Manufacturer Narrative
Date sent to the fda: 11/18/2020.Additional information: d1, d4, h4.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
Manufacturer Narrative
Date sent to fda: 11/3/2020.Additional b5 narrative: it was reported that the patient experienced hernia recurrence following the surgery.
 
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Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key10178739
MDR Text Key195917393
Report Number2210968-2020-04653
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K060713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup
Report Date 06/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/31/2016
Device Catalogue NumberPCDN1
Device Lot NumberHDG067
Was Device Available for Evaluation? No
Date Manufacturer Received11/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age43 YR
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