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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US ,LLC COLOPLAST RESTORELLE MESH MESH, SURGICAL, POLYMERIC

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COLOPLAST MANUFACTURING US ,LLC COLOPLAST RESTORELLE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number 501440
Device Problem Positioning Problem (3009)
Patient Problems Incontinence (1928); Pain (1994); Urinary Retention (2119)
Event Date 03/16/2018
Event Type  Injury  
Event Description

Doctor (urogyn) in (b)(6) said i needed to have a hysterectomy, sacrocolpopexy with mesh and mid-urethral sling. My one and only complaint was a bulge in anterior compartment which didn't hurt. I also didn't have sui. Doctor insisted i have the above major surgery to correct the problem. I continually asked about the dangers of mesh. His answer was this is the new mesh, if i use vaginal estrogen i won't have any problems. After surgery (b)(6), i had to go to the er when my bladder locked up due to the j&j mid -urethral sling. Urge incontinence was terrible after the implant. I had to have sacrocolpopexy mesh (coloplast restorelle) removed after 9 months due to pain in vagina and i had pain that was in my upper vagina and rectum. I believed that was due to healing. But on (b)(6) 2018 i had to go to the er because my bladder locked up. This continued to happen if i didn't go to the bathroom often. I went in for my post op check in (b)(6). Doctor said "my vagina looked so good no one would ever know i had children". I was cleared to have intercourse. I tried several days later and it was excruciating. I couldn't have penetrating intercourse. I went to see my ob/gyn about the problem. They gave me estrogen and said vagina was very tight. Even after the estrogen, i couldn't have sex. The pain in my vagina had become like a mini jackhammer beating in me. My rectal pain was terrible if i would stand for too long. I started looking for a doctor to remove the mesh. No doctor in (b)(6) can do a complete mesh removal, so i looked out of state. I visited a doctor in (b)(6) first. Second opinion in (b)(6). Both doctors said i was having some kind of an adverse reaction to the mesh. I decided to have it removed in (b)(6). This was on (b)(6) 2018. It was a 9 hour surgery and 3 day hospital stay. I can send all my records from surgeries.

 
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Brand NameCOLOPLAST RESTORELLE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COLOPLAST MANUFACTURING US ,LLC
MDR Report Key8545599
MDR Text Key143217228
Report NumberMW5086103
Device Sequence Number2
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 04/14/2019
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received04/23/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number501440
Device LOT Number5716491
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/23/2019 Patient Sequence Number: 1
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