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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); Nausea (1970); Pain (1994); Scar Tissue (2060); Hernia (2240); Decreased Appetite (4569); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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.
 
Event Description
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2019 and mesh was implanted. It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2020 during which the surgeon noted he encountered and removed the previously placed mesh from the entry abdominal wall. Some of the involved abdominal wall was then excised where there was significant induration noted. It was reported that the patient experienced severe intractable pain, inflammation, nausea, dense adhesions, infection, bulging, scarring, loss of appetite, stress and anxiety. No additional information was provided.
 
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Brand NamePROCEED MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-CORNELIA
655 ethicon circle
cornelia GA 30531
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12523831
MDR Text Key273368479
Report Number2210968-2021-08823
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 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2021
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 Received02/10/2022
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: 09/23/2021 Patient Sequence Number: 1
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