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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S SABRE SLING SURGICAL MESH

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COLOPLAST A/S SABRE SLING SURGICAL MESH Back to Search Results
Model Number 5194901000
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Fever (1858); Micturition Urgency (1871); Headache (1880); Incontinence (1928); Urinary Tract Infection (2120); Burning Sensation (2146); Chills (2191); Urinary Frequency (2275); Arthralgia (2355); Neck Pain (2433); Hematuria (2558)
Event Date 02/05/2003
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 symptomatic partial pubovaginal sling excision, neurogenic bladder, urine retention, urinary diversion was done and an ileal chimney procedure, stress urinary incontinence, injection of transurethral bulking agent, take down of ileal chimney diversion, blood in urine, burning sensation on urination, abdominal pain, mixed incontinence, fever, headache, chills, joint pain, neck and back pain, small rectocele, small cystocele, nocturia, urgency, frequency, uti, chronic abdominal pain, lysis of adhesions done.
 
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Brand NameSABRE SLING
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 river road north
minneapolis MN 55411
Manufacturer Contact
christine buckvold
MDR Report Key6389270
MDR Text Key69442927
Report Number2125050-2017-00047
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 03/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number5194901000
Device Catalogue Number5194901000
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/08/2017 Patient Sequence Number: 1
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