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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S (2BO) RESTORELLE DIRECT FIX A SURGICAL MESH
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COLOPLAST A/S (2BO) RESTORELLE DIRECT FIX A SURGICAL MESH Back to Search Results
Model Number 5013601400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Incontinence (1928); Pain (1994); Prolapse (2475)
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, patient's legal representative stated interstitial cystitis, pop, sui, possible intrinsic sphincter deficiency, grade 2 cystocele, grade 2 rectocele, grade 2 enterocele, grade 1-2 uterine vault prolapse. Placement of restorelle pk, restorelle ak, and desara sling completed under general anesthesia. Recurrent cystocele, no mesh exposure, cystocele repair if requested for moderate prolapse.
 
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Brand Name(2BO) RESTORELLE DIRECT FIX A
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
christine buckvold
1601 west river road north
minneapolis, MN 55411
6123024982
MDR Report Key6170005
MDR Text Key62241991
Report Number2125050-2016-00373
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,other
Type of Report Initial
Report Date 12/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number5013601400
Device Catalogue Number5013601400
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2016
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: 12/13/2016 Patient Sequence Number: 1
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