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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 PCDH1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Hernia (2240); Obstruction/Occlusion (2422); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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.
Event Description
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2007 and two (2) mesh products were implanted. It was reported that the patient underwent removal surgery on (b)(6) 2014 during which the surgeon noted meshoma with both previously placed pieces of infected mesh, abdominal wall debridement including skin, subcutaneous tissue, muscle and fascia. He performed a wedge resection of the right lobe of the liver that was involved intimately with epigastric meshoma. It was reported that the patient experienced severe pain and inflammation. No additional information was provided.
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Type of DeviceMesh, surgical, polymeric
Manufacturer (Section D)
route 22 west
somerville NJ 08876
Manufacturer (Section G)
655 ethicon circle
cornelia GA 30531
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key14672993
MDR Text Key293911721
Report Number2210968-2022-04491
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Expiration Date06/30/2008
Device Model NumberPCDH1
Device Catalogue NumberPCDH1
Device Lot NumberZHG458
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Date Manufacturer Received08/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/03/2007
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/13/2022 Patient Sequence Number: 1