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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE DIRECTFIX POSTERIOR SURGICAL MESH
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COLOPLAST A/S RESTORELLE DIRECTFIX POSTERIOR SURGICAL MESH Back to Search Results
Model Number 5014602400
Device Problem Insufficient Information (3190)
Patient Problems Incontinence (1928); Pain (1994); Prolapse (2475)
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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, patient's legal representative stated severe pain, vaginal prolapse, urinary incontinence, physical deformity, the loss of the ability to perform sexually, serious and permanent physical and emotional injuries, erosion of the vaginal wall and other tissues, infection, permanent and substantial physical deformity. A revision surgery occurred to excise and remove a portion of the restorelle mesh. Patient also had restorelle directfix anterior and altis single incision sling system reported under 2125050-2020-00705 and 2125050-2020-00706.

 
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Brand NameRESTORELLE DIRECTFIX POSTERIOR
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
uslpri lauren prioleau
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key10410687
MDR Text Key203089621
Report Number2125050-2020-00704
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK103568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Type of Report Initial
Report Date 08/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/14/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5014602400
Device Catalogue Number501460
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 08/14/2020 Patient Sequence Number: 1
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