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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 Migration (4003)
Patient Problems Erosion (1750); Incontinence (1928); Urinary Tract Infection (2120); Not Applicable (3189)
Event Date 01/01/2016
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.Adverse event about erosion found in 2016 and mesh removal in 2017 was submitted by medwatch report 2210968-2019-91302.
 
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.The patient was still seeing a doctor for severe urinary incontinence and recurrent urinary tract infections and in 2016 it was found that there was a mesh urethral sling in place and there was erosion of the tape at that point.A doctor opined that it is impossible to dissect the mesh out.The patient reported that in 2016 the patient had also a prolapse in the bowel and in 2017 this eventually led to another operation in bowel and there it was discovered that the mesh had moved from the bowel to the bladder.As per doctor, in 2017, a hydronephrosis of the patient¿s right kidney with unknown etiology was found, and due to recurrent uti¿s, severe urinary incontinence and severe unfixable pelvic floor dysfunction, the patient underwent a cystectomy with ileal conduit to resolve the patient¿s problems.The mesh was removed with all tissue at that time.This surgery has been very successful to date.
 
Manufacturer Narrative
Date sent to the fda: 01/02/2020.Corrected information: adverse event regarding severe fecal incontinence, urinary incontinence and pelvic floor dysfunction in 2010 and abdominoperineal resection in 2015 was submitted via medwatch report 2210968-2019-91302.
 
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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
MDR Report Key9520812
MDR Text Key189000440
Report Number2210968-2019-91305
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
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
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
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