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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Hematoma (1884); Nausea (1970); Pain (1994); Scar Tissue (2060); Seroma (2069); Vomiting (2144); Numbness (2415); Constipation (3274); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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) 2015 and mesh was implanted. It was reported that the patient underwent removal surgery on (b)(6) 2016 during which the surgeon noted extensive adhesions along the area of the colon and the mesh was removed in part. Next all the non incorporated mesh was removed after careful sharp dissection wall adhesed components of small bowel and colon. It was reported that the patient experienced scarring, pain, tenderness, numbness, tingling, bulging, nausea, emesis, digestive issues, constipation, seroma, hematoma, adhesions, diastasis, bowel involvement, serosal defect, wound drainage, mental anguish and anxiety. 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 30531
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key13896419
MDR Text Key288047395
Report Number2210968-2022-02121
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 03/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2016
Device Model NumberPCDH1
Device Catalogue NumberPCDH1
Device Lot NumberHHG145
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/16/2014
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: 03/24/2022 Patient Sequence Number: 1
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