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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S UNKNOWN FEM PELVIC HEALTH MESH SURIGCAL MESH

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COLOPLAST A/S UNKNOWN FEM PELVIC HEALTH MESH SURIGCAL MESH Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Complaint, Ill-Defined (2331); Hematuria (2558)
Event Date 09/11/2007
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, the patient's legal representative stated pain, urinary problems, bowel problems, infection, hematuria, and bleeding. The product information for the implanted device was not available at the time of the complaint.
 
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Brand NameUNKNOWN FEM PELVIC HEALTH MESH
Type of DeviceSURIGCAL MESH
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, DK-30 50
DA DK-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 Key5936694
MDR Text Key54211763
Report Number2125050-2016-00209
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial
Report Date 09/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2016
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: 09/08/2016 Patient Sequence Number: 1
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