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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S SUPRIS RETROPUBIC SLING SYSTEM; SURGICAL MESH

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COLOPLAST A/S SUPRIS RETROPUBIC SLING SYSTEM; SURGICAL MESH Back to Search Results
Model Number 5195612400
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Bacterial Infection (1735); Foreign Body Reaction (1868); Pain (1994); Urinary Retention (2119); Burning Sensation (2146)
Event Type  Injury  
Manufacturer Narrative
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
 
Event Description
As reported to coloplast, though not verified, the patient with this device experienced foreign body reaction, pain, dyspareunia, difficulty voiding, difficulty emptying her bladder, burning sensation, infections and other unspecified injuries.It is unknown if or how the patient received treatment for these complications and if the device remains implanted.
 
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Brand Name
SUPRIS RETROPUBIC SLING SYSTEM
Type of Device
SURGICAL MESH
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebæk 3050
DA  3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
usaby angela kilian
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key12170901
MDR Text Key261683642
Report Number2125050-2021-00914
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
PMA/PMN Number
K111233
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 07/15/2021
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? Yes
Device Operator Health Professional
Device Model Number5195612400
Device Catalogue Number519561
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/17/2021
Initial Date FDA Received07/14/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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