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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROCEED VENTRAL PATCH::SIZE 4.3 X 4.3 CM MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROCEED VENTRAL PATCH::SIZE 4.3 X 4.3 CM MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PVPS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pain (1994); Weight Changes (2607)
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) 2019. (b)(4) submitted for adverse event which occurred on (b)(6) 2019. (b)(4) submitted for adverse event which occurred on (b)(6) 2020.
 
Event Description
It was reported by an attorney that the patient underwent recurrent hernia repair surgery on (b)(6) 2012 and mesh was implanted. It was reported that the patient underwent additional surgery on (b)(6) 2019 during which the surgeon noted the prior mesh was protruding. Portions of the protruding mesh and recurrent hernia contents were removed. It was reported that the patient underwent removal surgery on (b)(6) 2019 during which the surgeon noted he removed the infected mesh. It was reported that the patient underwent additional surgery on (b)(6) 2020 during which the surgeon noted he found and lysed significant abdominal wall adhesions. It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss. It was reported that patient had a previous hernia repair surgery on (b)(6) 2010 and mesh was implanted. Other procedure was captured in a separate file. No additional information was provided.
 
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Brand NamePROCEED VENTRAL PATCH::SIZE 4.3 X 4.3 CM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08876
Manufacturer (Section G)
ETHICON INC.-GMBH
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082182213
MDR Report Key11098454
MDR Text Key226266284
Report Number2210968-2020-10419
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2012
Device Model NumberPVPS
Device Catalogue NumberXCPVPS
Device Lot NumberDP8JPGZ0
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/22/2011
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: 12/30/2020 Patient Sequence Number: 1
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