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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 Insufficient Information (3190)
Patient Problems Abdominal Pain (1685); Micturition Urgency (1871); Incontinence (1928); Muscular Rigidity (1968); Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Prolapse (2475); Abdominal Cramps (2543); Hematuria (2558); Intermenstrual Bleeding (2665); No Information (3190); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

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, the patient's legal representative stated pain, pelvic floor spasticity.

 
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Brand NameRESTORELLE DIRECTFIX ANTERIOR
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, da 3050
DA 3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
sarah o'gara
1601 west river road north
minneapolis, mn, MN 55411
6123024982
MDR Report Key6033625
MDR Text Key57618362
Report Number2125050-2016-00299
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 CONSUMER,OTHER
Type of Report Initial,Followup
Report Date 06/03/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/17/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL Number5014502400
Device Catalogue Number5014502400
Device LOT Number4126809
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 10/17/2016 Patient Sequence Number: 1
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