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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 288285
Device Problems Material Erosion (1214); Extrusion (2934)
Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Perforation (2001); Scarring (2061); Complaint, Ill-Defined (2331)
Event Date 06/01/2010
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 pain, erosion, extrusion, exposure, urinary and bowel problems, organ perforation, fistulae, infection, bleeding, dyspareunia, neuromuscular problems, vaginal scarring, excision, severe lower back pain; can not have kids now, removed uterus.
 
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Brand Name
RESTORELLE DIRECTFIX ANTERIOR
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 Key5868595
MDR Text Key51849842
Report Number2125050-2016-00151
Device Sequence Number1
Product Code FTL
UDI-Device Identifier5013601400
UDI-Public5013601400
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 08/10/2016
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 Number288285
Device Catalogue Number288285
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/26/2016
Initial Date FDA Received08/11/2016
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 Age40 YR
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