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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ETHICON MESH UNKNOWN; MESH, SURGICAL, POLYMERIC
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ETHICON INC. ETHICON MESH UNKNOWN; MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Tears, rips, holes in device, device material (1628)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
It was reported by the patient, in response to a you tube video that the patient had a ventral open hernia repair in 2011.The patient did not see a difference.Now in 2015, the patient reports that the hernia repair with mesh has tore apart and tore on the other side which is painful.The patient will not go to the surgeon who placed the mesh.The patient is now "starting over again." no additional information was provided.
 
Manufacturer Narrative
(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
 
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Brand Name
ETHICON MESH UNKNOWN
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 015
Manufacturer (Section G)
UNKNOWN
unknown
x
Manufacturer Contact
mary szaro
route 22 west po box 151
somerville, NJ 08876
9082183464
MDR Report Key4953415
MDR Text Key17633027
Report Number2210968-2015-10156
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 07/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/09/2015
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
Patient Sequence Number1
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