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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
Model Number PCDJ1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Diarrhea (1811); Nausea (1970); Chills (2191)
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) 2010. (b)(4) submitted for adverse event which occurred on (b)(6) 2011.

 
Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2007 and mesh was implanted. It was reported that the patient underwent revision surgery on (b)(6) 2010 during which the surgeon noted he performed an extensive lysis of adhesions, to take down the adhesions of omentum to the old mesh. There was one very densely adherent loop of bowel to the edge of the mesh at the hernia defect. It was reported that the patient underwent hernia repair surgery on (b)(6) 2011 and mesh was implanted. It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss. The other procedure is captured in a separate file. No additional information was provided.

 
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Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-CORNELIA
655 ethicon circle
cornelia GA 30531
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082182213
MDR Report Key10956359
MDR Text Key219873753
Report Number2210968-2020-09633
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK060713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 12/03/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/07/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPCDJ1
Device Catalogue NumberPCDJ1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 12/07/2020 Patient Sequence Number: 1
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