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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 Migration (4003)
Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Diarrhea (1811); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); 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.
 
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) 2020 during which the surgeon noted infected mesh eroding into the small bowl with enterocutaneous fistulas and abscess. The infected mesh was removed, fistulas taken down, abscess drained and bowel resected. It was reported that the patient experienced severe pain, infection, infected mesh, dense adhesions, small bowel erosion and enterotomies, small bowel resection, fistulas, abscesses, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss. 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
9083863534
MDR Report Key15222997
MDR Text Key297859355
Report Number2210968-2022-06591
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10705031047723
UDI-Public10705031047723
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
Report Date 08/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPCDH1
Device Catalogue NumberPCDH1
Device Lot NumberZPG8B9
Was Device Available for Evaluation? No
Date Manufacturer Received08/11/2022
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: 08/14/2022 Patient Sequence Number: 1
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