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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); Chills (2191); Obstruction/Occlusion (2422); Weight Changes (2607); Decreased Appetite (4569)
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. Mwr-11082021-0001016027 submitted for adverse event which occurred on (b)(6) 2008. Mwr-11082021-0001016029 submitted for adverse event which occurred on (b)(6) 2010.
 
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 removal surgery and hernia repair surgery on (b)(6) 2008 and mesh was implanted during which the surgeon noted the left edge of the fascia was separating from the mesh, as well as one segment of the bowel that was stuck to the mesh and was very friable. It was reported that the patient underwent removal surgery on (b)(6) 2010 during which the surgeon noted the small bowel to be densely adherent to the mesh, resulting in a resection of the portion of the bowel and mesh attached to it. 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.
 
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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 Key12310847
MDR Text Key266173769
Report Number2210968-2021-07256
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 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2021
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
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2021
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: 08/11/2021 Patient Sequence Number: 1
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