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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 PCDG1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Scarring (2061); Cramp(s) (2193)
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.(b)(4) submitted for adverse event which occurred on (b)(6) 2012.(b)(4) submitted for adverse event which occurred on (b)(6) 2017.
 
Event Description
It was reported by an attorney that the patient underwent incisional hernia repair surgery on (b)(6) 2009 and mesh was implanted.It was reported that the patient underwent partial excision on (b)(6) 2012 during which the surgeon noted a portion of the mesh had come into the bladder.Some of the mesh was destroyed by the laser fiber, and some had to be pulled off and separated from the bladder.It was reported that the patient underwent removal of the remaining mesh on (b)(6) 2017 during which the surgeon noted mesh adherent to the bladder wall, which was dissected and removed.It was reported that the patient experienced severe pain, organ damage, mesh migration, cramping, scarring, inflammation, nausea, stress and anxiety.No additional information is provided.
 
Manufacturer Narrative
Date sent to fda: 8/26/2020.Additional information: a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
Manufacturer Narrative
Date sent to fda: (b)(6) 2020.
 
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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 0151
MDR Report Key8847303
MDR Text Key152833974
Report Number2210968-2019-84877
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 07/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2011
Device Catalogue NumberPCDG1
Device Lot NumberBKG462
Was Device Available for Evaluation? No
Date Manufacturer Received08/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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