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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROCEED MESH 6INX6IN(15CMX15CM) SQ MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROCEED MESH 6INX6IN(15CMX15CM) SQ MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCDM1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Weight Changes (2607); Decreased Appetite (4569)
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. (b)(4) submitted for adverse event which occurred on an unknown date. (b)(4) submitted for adverse event which occurred on (b)(6) 2018.

 
Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2013 and mesh was implanted. It was reported that the patient underwent removal surgery during which the surgeon noted ¿the mesh was found to be separated on the superior right lateral side and had reflected inferiorly on the left. It was reported that the patient underwent revision surgery on (b)(6) 2018 during which the surgeon noted ¿there was a large amount of adhesions to the small bowel and omentum to the abdominal wall. ¿ it was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss. No additional information was provided.

 
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Brand NamePROCEED MESH 6INX6IN(15CMX15CM) SQ
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 Key11272362
MDR Text Key230040365
Report Number2210968-2021-01017
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 01/29/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/03/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPCDM1
Device Catalogue NumberPCDM1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2021
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: 02/03/2021 Patient Sequence Number: 1
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