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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST AXIS DERMIS SLING; MESH

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COLOPLAST AXIS DERMIS SLING; MESH Back to Search Results
Lot Number 101087537
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Staphylococcus Aureus (2058); Cramp(s) (2193); Discharge (2225); Complaint, Ill-Defined (2331)
Event Type  Other  
Event Description
Hi, i just would like to let you know that i had tvt implant done (b)(6) 2015 for stress incontinence and mix incontinence due to axis dermis sling that was done (b)(6) 2014 included to the reported sling done (b)(6) 2014 which none of them helped, as it made it much worse.I had gynecare ethicon tvt mesh part of johnson johnson (b)(4) implanted by dr (b)(6).Started to notice complications about 1.5 to 2 months after surgery.Vaginal implant on (b)(6) 2015 the symptoms was and still is: bleeding, discharging, mix incontinence, self cath, indwelling cath, sharp - severe cramping in pelvic.Bladder burning, contraction pain in abdomen.Uti - sui - staph infections have been and still on the daily antibiotic for uti.I have been on the same daily antibiotic since 2015 after vaginal implant surgery of (b)(6) 2015.I was told this implant would help my stress and mix incontinence he says this would keep me dry; wrong.I never was once told that this mesh couldn't be removed, i never was told about this dangerous side effect.I never was told about any of these complications.No instruction was given to me before these implant.I only notice once i started to experience some complications that it led me to e.R.On (b)(6) 2015 had go for office visits in (b)(6) 4.5 hours away.All they say would make it better with no leakage.But no promise of a fix.Was no instruction about serious-severe complications.No warnings as they said was still option with no leakage.I would stay dry they say.None of these implant help instead it made it very much much worse, i'm upset and agree that i went through all these implant surgeries and none of them are helping as the manufacturer should take these off the shelves, off the market asap.Why are we or am i reporting to you folks when there's a problem, well this is a serious problem that you folks, if you have the power over these manufacturers have them to stop selling these to doctors and have them take this vaginal implant off the market, please.The more vaginal implants these doctor do the more scarring tissues will have and not go away.From the implant scarring dr says could be the cause of my severe pelvic pain along with daily antibiotic treated for uti.When i started to have severe chronic cramping like labor pain and contracting ongoing pain scarring, bleeding, infection ongoing surgery, stress 3 incontinence, sharp pelvic - abdomen pain - keeps me awake at night.These implants are worthless.Was told these implants are supposed to help stress incontinence not to destroy a woman's body.Never was told about these severe complication, was never told about any warning.Was not told about these side effect or infections, was never told about these scarring tissues that would cause me pain only found out 2015.After implant complications i asked the dr if i could have the mesh removed once i started to experience all these severe complications and being on daily antibiotic since 2015 as it's not helping my incontinence, just makes everything worse not better.Dr of urology of 2015 says no this cannot be removed, wouldn't be possible, if they try to remove this mesh would take several surgeries.Would be major complications that would take me further distance to (b)(6), than again don't think it's possible.Gynecare mesh wrapped around scarring tissues.
 
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Brand Name
AXIS DERMIS SLING
Type of Device
MESH
Manufacturer (Section D)
COLOPLAST
MDR Report Key5946196
MDR Text Key55742818
Report NumberMW5064707
Device Sequence Number2
Product Code FTM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received09/12/2016
Device Operator No Information
Device Lot Number101087537
Type of Device Usage N
Patient Sequence Number1
Treatment
AXIS DERMIS, COLOPLAST; COLLAGEN; COLLAGEN; COLLAGEN; COLLAGEN IMPLANT, ARTEGRAFT; COLLAGEN, BARD; INCISION URETHRA SLING; JOHNSON AND JOHNSON; MACROPLASTIQUE IMPLANT; MACROPLASTIQUE IMPLANT, UROPLASTY; PACEMAKER IMPLANT, INTERSTIM-MEDTRONIC; PHASE 1 IMPLANT; PHASE 2 IMPLANT; REPEAT AND CHANGE BATTERY IMPLANT BETTER STORAGE; VAGINAL IMPLANT, TVT MESH GYNECARE ETHICON
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