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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROCEED MULTI-LAYER LAMINATE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROCEED MULTI-LAYER LAMINATE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problems Hole In Material (1293); Appropriate Term/Code Not Available (3191)
Patient Problems Hernia (2240); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Attempts have been made to retrieve the device. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported in a journal article that the patient underwent a laparoscopic repair of perineal hernia procedure on unknown date and mesh was implanted. During the procedure, the mesh was tacked to the promontory or sacrum and sutured to the pelvic sidewalls and the anterior peritoneum. Twelve months after procedure, the patient experienced recurrence and had a rupture in the center of the mesh. The patient underwent a laparoscopic reoperation. There were no adhesion to the mesh noted during reoperation and another like mesh was sutured to the first mesh. No signs of recurrence were seen six months after reoperation. No further information is available.
 
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Brand NamePROCEED MULTI-LAYER LAMINATE MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-CORNELIA
655 ethicon circle
cornelia GA 30531
Manufacturer Contact
kenneth clark
route 22 westp o box 151
somerville, NJ 08876
9082183547
MDR Report Key5708990
MDR Text Key46892188
Report Number2210968-2016-09635
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K060713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received05/19/2016
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: 06/09/2016 Patient Sequence Number: 1
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