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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S VIRTUE; SURGICAL MESH

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COLOPLAST A/S VIRTUE; SURGICAL MESH Back to Search Results
Model Number 5002001400
Device Problem Insufficient Information (3190)
Patient Problems Wound Dehiscence (1154); Pain (1994); Urinary Retention (2119)
Event Type  Injury  
Manufacturer Narrative
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
 
Event Description
According to the available information, an abstract article - 48 patients were treated with the virtue sling.Transient pain was the most common adverse event, occurring in 23 of patients.Other reported complications indicated transient urinary retention and wound dehiscence.
 
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Brand Name
VIRTUE
Type of Device
SURGICAL MESH
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek 3050
DA  3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west rivier road north
minneapolis MN 55411
Manufacturer Contact
sarah o'gara
1601 west rivier road north
minneapolis, MN 55411
6123578517
MDR Report Key8552182
MDR Text Key143139753
Report Number2125050-2019-00320
Device Sequence Number1
Product Code OTM
Combination Product (y/n)N
PMA/PMN Number
K101297
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,litera
Type of Report Initial
Report Date 04/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number5002001400
Device Catalogue Number500200
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/27/2019
Initial Date FDA Received04/25/2019
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? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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