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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); Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); Perforation (2001); Chills (2191); Weight Changes (2607); Decreased Appetite (4569)
Event Type  Injury  
Event Description
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2009 and mesh was implanted. It was reported that the patient underwent removal surgery on (b)(6) 2009 and mesh was implanted during which the surgeon noted significant blood superior to the mesh. The mesh was removed exposing a large hematoma, which was evacuated. It was reported that the patient underwent removal surgery on (b)(6) 2010 during which the surgeon noted there were loops of bowel adherent to the mesh, the lysing of which resulted in perforation of the bowel. The contaminated mesh was removed with great care to cause the least amount of trauma to the abdominal wall as possible. It was reported that the patient underwent a surgical procedure on (b)(6) 2010. It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss. 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. Mwr-(b)(4): submitted for adverse event which occurred on (b)(6) 2009. Mwr-(b)(4): submitted for adverse event which occurred on (b)(6) 2010. Mwr-(b)(4): submitted for adverse event which occurred on (b)(6) 2010.
 
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Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
MDR Report Key12741699
MDR Text Key284975573
Report Number2210968-2021-10781
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K060713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPCDG1
Device Catalogue NumberPCDG1
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2021
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: 11/02/2021 Patient Sequence Number: 1
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