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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
Model Number 5014502400
Device Problem Insufficient Information (3190)
Patient Problems Abdominal Pain (1685); Micturition Urgency (1871); Incontinence (1928); Muscular Rigidity (1968); Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Prolapse (2475); Abdominal Cramps (2543); Hematuria (2558); Intermenstrual Bleeding (2665); No Information (3190); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
The follow-up is created to document the additional information. The lot # was reviewed for complaint trend, nonconforming report and capa. Devices met specification prior to release and no trends were noted. (b)(4). Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
 
Event Description
As reported to coloplast, additional information received stated urge incontinence, continued incontinence, and hematuria were noted. The mesh was removed. Additional information stated back/abdominal pain unchanged from prior to cystocele correction, more urinary leakage with frequency/urgency, constant pelvic/vaginal/bladder pain, new onset sui with multiple episodes of ui daily enough to wet outerwear; wears several pads/day, urinary urgency/leakage with cough, feels she needs to strain in order to empty bladder, post void dribble, vaginal discharge that increased after prior pfpt treatment that changed to pink tinged, claimant stated she felt ball at vaginal opening when sitting to void, menstrual cramp feeling in bladder and vagina, also with sharp vaginal pain, dyspareunia/has to stop during intercourse due to the pain, daily sui symptoms, episodes of sharp vaginal pain have decreased, decreased sui symptoms now with only drops of incontinence, continued debilitating pelvic pain that is worse with full bladder, 60% response to pfpt, continues to have urinary urgency/frequency, no ui. (b)(6) 2016 - complete removal of restorelle, anterior colporrhaphy, cystoscopy, bilateral trigger point injections excision size 5 x 5 x 1 cm, intraoperative findings: restorelle lying very well in anterior vagina without significant tension, grade 2 cystocele discovered and repaired.
 
Manufacturer Narrative
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
 
Event Description
As reported to coloplast, though not verified, the patient's legal representative stated pain, pelvic floor spasticity.
 
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Brand NameRESTORELLE DIRECTFIX ANTERIOR
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, da 3050
DA 3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
sarah o'gara
1601 west river road north
minneapolis, mn, MN 55411
6123024982
MDR Report Key6033625
MDR Text Key257288803
Report Number2125050-2016-00299
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K103568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 06/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number5014502400
Device Catalogue Number5014502400
Device Lot Number4126809
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/17/2016 Patient Sequence Number: 1
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