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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE DIRECT FIX A LOT NUMBER: SURGICAL MESH

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COLOPLAST A/S RESTORELLE DIRECT FIX A LOT NUMBER: SURGICAL MESH Back to Search Results
Model Number 5013601400
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Adhesion(s) (1695); Nausea (1970); Pain (1994); Scarring (2061); Urinary Tract Infection (2120); Prolapse (2475); Hematuria (2558)
Event Date 12/13/2010
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, the patient's legal representative stated prolapse, documentation of poor support of anterior restorelle y secondary due to difficulty with placement secondary to prior adhesions, tight banding from midline anterior vaginal wall to posterior vaginal wall, multiple lines of vaginal scarring anterior/posterior, unable to perform adl's/exercise/sleep secondary to pelvic pain/pressure, right inguinal, pain with bowel movements, dyspareunia with nausea, unable to engage in physical activity secondary to chronic pelvic pain, perineal pain with neuropathic features, vaginal heaviness, and multiple uti's with hematuria.
 
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Brand NameRESTORELLE DIRECT FIX A LOT NUMBER:
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 Key5981813
MDR Text Key55789293
Report Number2125050-2016-00231
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 09/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2016
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 Received09/26/2016
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: 09/27/2016 Patient Sequence Number: 1
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