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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 PCDG1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Inflammation (1932); Pain (1994); Hernia (2240)
Event Type  Injury  
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 and recurrent hernia repair surgery on (b)(6) 2009 and mesh was implanted during which the surgeon noted adhesions to the omentum and a dense adhesion to the hernia sac. It was reported that the patient underwent revision surgery on (b)(6) 2011 during which the surgeon noted dense adhesions between the small bowel and the mesh and damage to part of the small bowel, requiring the need for a bowel resection. It was reported that the patient underwent revision surgery on (b)(6) 2012 during which the surgeon noted part of the small intestine had come through the mesh and stuck to the fascia and significant adhesions. It was reported that the patient experienced severe pain and inflammation. Other procedure is captured under separate file. No additional information was provided.
 
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. (b)(4) submitted for adverse event which occurred on (b)(6) 2009. (b)(4) submitted for adverse event which occurred on (b)(6) 2011. (b)(4) submitted for adverse event which occurred on (b)(6) 2012.
 
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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 Key14520284
MDR Text Key292797214
Report Number2210968-2022-04113
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 05/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPCDG1
Device Catalogue NumberPCDG1
Device Lot NumberAKG542
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/13/2022
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: 05/27/2022 Patient Sequence Number: 1
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