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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 Extrusion (2934)
Patient Problem Erosion (1750)
Event Date 08/01/2012
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 extrusion, erosion and recurrent cystocele.
 
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Brand Name
(2BO) RESTORELLE DIRECTFIX ANT
Type of Device
SURGICAL 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 Key6170945
MDR Text Key62262489
Report Number2125050-2016-00375
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model Number5014501400
Device Catalogue Number5014501400
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/07/2016
Initial Date FDA Received12/13/2016
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 N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age49 YR
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