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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROCEED MESH MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROCEED MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Inflammation (1932); Scarring (2061)
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) 2008. (b)(4) submitted for adverse event which occurred on (b)(6) 2012.
 
Event Description
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2008 and mesh was implanted. It was reported that the patient underwent revision surgery on (b)(6) 2008 and on (b)(6) 2012. It was reported that the patient experienced severe and chronic pain, inflammation, adhesions, mesh invading into the dome of the bladder, scarring and mesh separation. It was reported that the patient had previously underwent hernia repair surgery on (b)(6) 2007 and mesh was implanted. Other implanted product is captured in a separate file. No additional information is provided.
 
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Brand NamePROCEED MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan 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
9082183429
MDR Report Key10554078
MDR Text Key207546949
Report Number2210968-2020-06975
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/10/2021
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: 09/18/2020 Patient Sequence Number: 1
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