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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE DIRECTFIX ANTERIOR SURGICAL MESH

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COLOPLAST A/S RESTORELLE DIRECTFIX ANTERIOR SURGICAL MESH Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Micturition Urgency (1871); Pain (1994); Scar Tissue (2060); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Prolapse (2475); Dysuria (2684); Dyspareunia (4505); Genital Bleeding (4507); Fecal Incontinence (4571); Urinary Incontinence (4572)
Event Type  Injury  
Manufacturer Narrative
Lot number: 110225-01. This event was previously reported under manufacturer report number 2125050-2016-00324. This report is intended to be a follow up report to submit additional information that has been received. Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
 
Event Description
Additional information received further reported that on the following dates the patient had experienced or was experiencing: (b)(6) 2011: urinary frequency. (b)(6) 2015: pelvic pain with uterine prolapse. (b)(6) 2016: uterine prolapse. (b)(6) 2016: stage ii recurrent prolapse, urgency, and stress urinary incontinence (sui). (b)(6) 2017: pain along the anterior proximal mesh and entire pelvic floor, sui, urgency, vaginal odor and occasional discharge, persistent groin pain that radiates down the legs and to the lower back, hypertonic pelvic floor 5/5 on right 4/5 on left with tight banding of apical portion of mesh extending toward sacrospinous ligaments. (b)(6) 2017: urinary urgency, urinary urge incontinence, and pelvic pain. (b)(6) 2017: pain along the distal mesh arms and proximal mesh band. (b)(6) 2017: banding of scar tissue in the proximal anterior portion of the vaginal wall across the width of the vagina, anterior vaginal wall pain, and left lower quadrant abdominal pain that radiates to the lower back and down the legs, incomplete bowel emptying, fecal incontinence, rectocele (stage 3), overactive bladder, and dyspareunia. Anterior mesh revision and cystoscopy took place under general anesthesia. Pathology: no mesh found in the specimen, predominantly scar tissue. (b)(6) 2018: rectocele to hymen, overactive bladder. (b)(6) 2021: stage ii uterovaginal prolapse, urge incontinence, overactive bladder. (b)(6) 2021: pelvic pain, urgency incontinence, posterior pelvic organ prolapse (stage ii).
 
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Brand NameRESTORELLE DIRECTFIX ANTERIOR
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebæk 3050
DA 3050
Manufacturer Contact
usaby angela kilian
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key11947127
MDR Text Key263480343
Report Number2125050-2021-00678
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/07/2021 Patient Sequence Number: 1
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