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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 Material Erosion (1214)
Patient Problems 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 event was previously reported under manufacturer report number 2125050-2019-01016; this report is intended to be a follow-up repot to submit additional information that has been received. (b)(4).
 
Event Description
Additional information received further reported that on (b)(6) 2017 the patient was experiencing or had experienced stabbing vaginal pain and a pulling sensation in her right groin, vaginal pressure, and clitoral pain. Mesh erosion occurred, approximately 1cm x 2cm on the right anterior wall approximately 4cm from introit. The patient also experienced myofascial tenderness, frequency due to suprapubic pressure and cramping, and often had to double void.
 
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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 Key12267658
MDR Text Key264925491
Report Number2125050-2021-01044
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial
Report Date 08/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number5014502400
Device Lot Number5241593
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2021
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

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