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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 PCDT1
Device Problem Migration (4003)
Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Necrosis (1971); Scar Tissue (2060); Sepsis (2067); Vomiting (2144); Obstruction/Occlusion (2422); Fibrosis (3167)
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) 2011 and mesh was implanted. It was reported that the patient underwent removal surgery on (b)(6) 2014 during which the surgeon noted the mesh had eroded into some of the small bowel. And there were extremely dense adhesions. One area of small bowel had to be resected due to the ingrowth of mesh into the small bowel. It was reported that the patient experienced scarring, digestive issues, nausea, vomiting, inflammation, adhesions, abscess, infection, ileus, fibrosis, necrosis, fibroadipose tissue, foreign body giant cell reaction, erosion, bowel obstruction, bowel resection, enterotomy, incision and drainage, open abdominal wound sepsis and incarcerated hernia. 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 Key13866584
MDR Text Key291483774
Report Number2210968-2022-02096
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
Report Date 03/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPCDT1
Device Catalogue NumberPCDT1
Was Device Available for Evaluation? No
Date Manufacturer Received03/18/2022
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: 03/23/2022 Patient Sequence Number: 1
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