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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 Abscess (1690); Adhesion(s) (1695); Inflammation (1932); Necrosis (1971); Pain (1994)
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 mesh was implanted. It was reported that the patient underwent removal surgery on (b)(6) 2009 during which the surgeon noted ¿there is a very large piece of mesh associated with sinus tract, which was approximately 25 cm in largest diameter. The mesh was removed in three sections. It was attached to omentum as well as transverse colon and multiple loops of small bowel. Additionally it was attached densely to the liver. ¿ it was reported that the patient experienced severe pain, inflammation, fat necrosis, abdominal wall abscess, bowel adhesions and liver adhesions. 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
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11946626
MDR Text Key255499001
Report Number2210968-2021-05308
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 06/04/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/07/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2021
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: 06/07/2021 Patient Sequence Number: 1
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