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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN
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ETHICON INC. GYNECARE MESH UNKNOWN Back to Search Results
Device Problem Other (for use when an appropriate device code cannot be identified) (2203)
Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)
Event Type  Injury  
Event Description
It was reported by an attorney that the patient underwent a gynecological procedure on an unknown date and an unknown mesh was implanted.It was reported that the patient experienced unspecified complications.No additional information has been provided.
 
Manufacturer Narrative
(b)(4).No conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
 
Manufacturer Narrative
It was reported that following insertion patient experienced incontinence and urgency.
 
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Brand Name
GYNECARE MESH UNKNOWN
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
UNKNOWN
unknown
x
Manufacturer Contact
mary szaro
route 22 west po box 151
somerville, NJ 08876
9082183464
MDR Report Key4958716
MDR Text Key15913997
Report Number2210968-2015-10489
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/04/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age56 YR
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