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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; SURGICAL MESH
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COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; SURGICAL MESH Back to Search Results
Model Number 5196501022
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Skin Erosion (2075); Dyspareunia (4505); Urinary Incontinence (4572)
Event Date 02/23/2021
Event Type  Injury  
Manufacturer Narrative
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.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, recurrent urinary incontinence and dyspareunia at a distance from an infra uretral sling placement.Erosion of the left vaginal fornix on its distal third by the left leg of the strip.Clinical consequences : strip removal, complete excision of the left and right branch 15 mm beyond the median axis.No other adverse patient effects were reported.
 
Manufacturer Narrative
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.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, recurrent urinary incontinence and dyspareunia at a distance from an infra uretral sling placement.Erosion of the left vaginal fornix on its distal third by the left leg of the strip.Clinical consequences : strip removal, complete excision of the left and right branch 15 mm beyond the median axis.No other adverse patient effects were reported.
 
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Brand Name
ALTIS SINGLE INCISION 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 Key13055922
MDR Text Key285610482
Report Number2125050-2021-01856
Device Sequence Number1
Product Code PAH
Combination Product (y/n)N
PMA/PMN Number
K121562
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/21/2021
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? No
Device Operator Health Professional
Device Model Number5196501022
Device Catalogue Number519650
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/10/2021
Initial Date FDA Received12/21/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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