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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S (2BO) RESTORELLE DIRECTFIX ANT SURGICAL MESH

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COLOPLAST A/S (2BO) RESTORELLE DIRECTFIX ANT SURGICAL MESH Back to Search Results
Model Number 5014501400
Device Problem Material Protrusion/Extrusion (2979)
Patient Problems Fever (1858); Incontinence (1928); Internal Organ Perforation (1987); Urinary Retention (2119); Obstruction/Occlusion (2422)
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, a clinical abstract stated: need for post-operative blood transfusion n
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3; urinary retention beyond 14 days n
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4; fever for 1-3 days n
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12; bladder perforation n
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1; left ureteric orifice was obscured at end-of-surgery cystoscopy n
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1 (this case subsequently developed renal impairment secondary to kinked ureter at the level of pelvic floor repair post-operatively requiring surgical removal of restorelle with concomitant anterior colporrhaphy); need for mesh loosening for urinary retention n
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1; abnormal urinary flow at one-month follow-up n
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2; de novo stress incontinence n
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1; mesh extrusion into vagina n
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1.
 
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Brand Name(2BO) RESTORELLE DIRECTFIX ANT
Type of DeviceSURGICAL 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
stephanie perryman
1601 west rivier road north
minneapolis, MN 55411
6124345685
MDR Report Key8337217
MDR Text Key136111244
Report Number2125050-2019-00109
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 company representative,foreig
Type of Report Initial
Report Date 02/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number5014501400
Device Catalogue Number501450
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2019
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? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/13/2019 Patient Sequence Number: 1
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