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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 Problem Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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. Additional information was requested and the following was obtained: please confirm that no issues were found with the securestrap device, i. E. Straps ripping. No issues with securestrap. Was there any damage to the packaging of the mesh? i. E. Holes. No damage to the mesh packaging.
 
Event Description
It was reported that the patient underwent an unknown surgical procedure on an unknown date and mesh was implanted. During the procedure, the surgeon found the device difficult to handle and reported that it stuck to underlying tissue. The mesh turned black with minimal contact with blood, and ripped in a few places where the absorbable straps were used to fixate the mesh. The procedure was completed with a like mesh device. There were no adverse patient consequences reported. No additional information was provided.
 
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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
darlene kyle
route 22 west po box 151
somerville, NJ 08876
9082182792
MDR Report Key6677821
MDR Text Key78791097
Report Number2210968-2017-32810
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCA
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 06/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 Received06/21/2017
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

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