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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER

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COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER Back to Search Results
Catalog Number 519650
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/27/2024
Event Type  malfunction  
Event Description
According to the available information the device would not maintain its tensioning.
 
Event Description
Additional information received on 3/6/2025 indicates the following: reportedly, the tensioning suture felt like it was "greased" and would not hold tension.A second sling was placed successfully.
 
Manufacturer Narrative
An altis sling was received for evaluation.Examination of the sling revealed no functional abnormalities.The dynamic and static anchors were still attached.Blood residue was noted on the sling.Based on examination of the returned product no functional anomalies were noted with the sling or anchors.The information received indicated when the physician went to tension the sling, it wasn't holding.The tensioning suture felt like it was "greased" and wouldn't hold tension.A second sling was placed successfully.A review of the device history record by the contract manufacturer confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.
 
Event Description
Additional information received on 3/6/2025 indicates the following: reportedly, the tensioning suture felt like it was "greased" and would not hold tension.A second sling was placed successfully.
 
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Brand Name
ALTIS SINGLE INCISION SLING SYSTEM
Type of Device
FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
Manufacturer (Section D)
COLOPLAST A/S
1 holtedam humlebaek, dk 3050
humlebaek 3050
DA  3050
Manufacturer Contact
usbes brian schmidt
1601 west river road n
minneapolis, MN 55411
MDR Report Key18960774
MDR Text Key338377612
Report Number2125050-2024-00468
Device Sequence Number1
Product Code PAH
UDI-Device Identifier05708932467407
UDI-Public05708932467407
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121562
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number519650
Device Lot Number9066452_5196502400
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/22/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/08/2024
Date Device Manufactured07/28/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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