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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Cramp(s) /Muscle Spasm(s) (4521); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
This mdr is created as an additional follow-up to mdr record # 2125050-2016-00299, initially reported on 03-jun-2020 through e-submitter. This mdr is to reflect the additional information received. According to the available information the patient¿s legal representative stated pain, pelvic floor spasticity. The restorelle directfix was implanted on (b)(6) 2015 and remains implanted. Corrective action: management routinely reviews events such as this and monitors complaint levels. Additionally, events of this type relating to the reported complaints are captured in the product risk documentation. Based on this, and because the device is not available for evaluation, no further corrective action is required at this time.
 
Event Description
As reported to coloplast, though not verified, additional information received 2/5/2021: between 6/3/2015-1/6/2016 back/abdominal pain unchanged from prior cystocele correction, more urinary leakage with frequency/urgency, vaginal atrophy, pelvic floor muscle spasms, pelvic/vaginal/bladder pain, new onset sui, urinary urgency/leakage with cough, feels she needs to strain in order to empty bladder, post void dribble, vaginal discharge, felt ¿ball¿ at vaginal opening when sitting to void, continued pelvic pain, sharp vaginal pain, dyspareunia/has to stop during intercourse due to pain. Removal of mesh (b)(6) 2016. Interoperative findings: mesh lying very well in anterior vagina without significant tension, grade 2 cystocele discovered and repaired. Post-operative urinary retention. (b)(6) 2016 - stabbing/cramping/vaginal bleeding since foley was removed. (b)(6) 2016 - vaginal bleeding x 2 months. (b)(6) 2016 - vaginal hematoma improved at 3 cm to the right side (b)(6) 2016 - no sensation to void, strain to urinate. (b)(6) 2018 - uti.
 
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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 (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
usaby angela kilian
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key12573852
MDR Text Key274692958
Report Number2125050-2021-01438
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number5014502400
Device Catalogue Number501450
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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