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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 5013801400
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Bacterial Infection (1735); Skin Erosion (2075)
Event Type  Injury  
Event Description
As reported to coloplast, though not verified, revision of vaginal mesh, anterior colpopexy, and vaginal vault suspension using restorelle ak under general anesthesia for vaginal mesh extrusion noted at mid urethra, midline and right fornix; mesh erosion located at posterior vaginal mucosa midline just medial to hymenal ring; anterior apical prolapse; and pelvic pain.
 
Manufacturer Narrative
This complaint was investigated to the extent information was provided to coloplast. Due to the legal nature of this complaint and the device not being returned for evaluation a thorough investigation could not be executed. Should additional information become available, this file will be re-evaluated and updated according to current procedures. Complaints of this nature are monitored and captured within the product risk documentation. No further action or corrective action is required at this time. Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
 
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Brand NameRESTORELLE DIRECTFIX ANTERIOR
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebæk 3050
DA 3050
MDR Report Key12389573
MDR Text Key280455512
Report Number2125050-2021-01215
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 08/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number5013801400
Device Catalogue Number501380
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2021
Is This a Reprocessed and Reused Single-Use Device?

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