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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN; MESH, SURGICAL
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ETHICON INC. GYNECARE MESH UNKNOWN; MESH, SURGICAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Incontinence (1928); Not Applicable (3189)
Event Date 01/01/2010
Event Type  Injury  
Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.
 
Event Description
It was reported that the patient underwent an unknown surgical procedure on unknown date and unknown mesh was implanted.In 2010 the patient was seen by a doctor for severe urinary incontinence and severe pelvic floor dysfunction.As it was reported, at that time both patient and doctor knew that she had a mesh in place.It was also reported that the colorectal surgeon performed an abdominoperineal resection with an end bowel stoma in 2015 for unfixable fecal incontinence.
 
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Brand Name
GYNECARE MESH UNKNOWN
Type of Device
MESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9520782
MDR Text Key189063574
Report Number2210968-2019-91302
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 12/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received12/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
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