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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 Erosion (1750); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Genital Bleeding (4507)
Event Date 03/10/2016
Event Type  Injury  
Manufacturer Narrative
According to the available information, the patient's legal representative reported pain, chronic uti, vaginal bleeding, urinary incontinence, vaginal discharge, mesh erosion. Restorelle l was implanted on (b)(6) 2016 and excised on (b)(6) 2016. 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. Coloplast has not been provided any corroborating evidence to verify the information contained in this report. Device not returned.
 
Event Description
As reported to coloplast, though not verified, patient's legal representative reported pain, chronic uti, vaginal bleeding, urinary incontinence, vaginal discharge, mesh erosion. Additional information received on 04/09/2021. Palpable mesh, overactive bladder, cystocele. (b)(6) 2016 - chronic uti after anterior repair. (b)(6) 2016 - eroded mesh. Cystourethroscopy with sounding, pelvic exam, excision of eroded vaginal mesh. Small exposed mesh vs suture, vaginal burning/pain. (b)(6) 2016 - cystourethroscopy with sound pelvic, mesh excision. (b)(6) 2016 - erosion. Laser ablation of eroded mesh and excision with closure of the vaginal mucosa with vaginoscopy and cystoscopy. Abdominal pain, fever, vaginal discharge, positive blood cultures. Exposure, grade 1 rectocele and cystocele, granulation tissue, tender right proximal limb. (b)(6) 2016 - chronic inflammation and necrotic tissue with mesh graft exposure in the left anterior vaginal wall and painful right proximal graft limb with palpable anchor. Excision of necrotic vaginal wall tissue and mesh graft material. Patch graft with a-cell graft and excision of bone anchor. Infected mesh. No other adverse patient effects were reported.
 
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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 Key12612104
MDR Text Key275925758
Report Number2125050-2021-01469
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
Type of Report Initial
Report Date 10/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number5014502400
Device Catalogue Number501450
Device Lot Number3812401
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2021
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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