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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S SUPRIS SUPRAPUBIC VAGINAL MESH SLING

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COLOPLAST A/S SUPRIS SUPRAPUBIC VAGINAL MESH SLING Back to Search Results
Lot Number 2093395
Event Date 12/01/2010
Event Type  Injury  
Event Description

On (b)(6), 2010, i had a large surgery. This included a total hysterectomy, an a/p repair (or posterior and anterior vaginal vault repair) and a mesh bladder sling. I had severe uterine prolapse which caused a cystocele and rectocele and i was leaking urine. A gynecologist did the hysterectomy and a/p repair and a urologist did the bladder sling. Neither doctor ever discussed that the fda had put out warnings in 2008 about the use of mesh slings. I began having problems with severe bleeding after sexual intercourse with my husband, pain and my husband was cut during intercourse. I went back to doctor who saw i had mesh erosion in my vagina. The urologist confirmed this and put me back on the operating table to cut out what was exposed. Then it happened again and i had another surgery on (b)(6), 2011 for more mesh erosion. I am still having the same problems but the doctors keep saying that they can not find anything. I am in constant pain, still bleed and now have additional problems such as loss of bowel control and feel as though i am still leaking urine at times. I hurt when i urinate as well and feel as though i constantly have a burning sensation at all times.

 
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Brand NameSUPRIS SUPRAPUBIC
Type of DeviceVAGINAL MESH SLING
Manufacturer (Section D)
COLOPLAST A/S
0543 305
DENMARK 0543 3050
MDR Report Key2166684
Report NumberMW5021349
Device Sequence Number1
Product CodeFTL
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/12/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/12/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date11/30/2013
Device LOT Number2093395
OTHER Device ID NumberREF 93-4450
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 07/12/2011 Patient Sequence Number: 1
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