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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 Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/05/2024
Event Type  malfunction  
Event Description
According to the available information, the thread between the mesh and the anchor frayed.The anchor remains implanted in the patient.
 
Manufacturer Narrative
The lot number was reviewed for complaint trend, non-conforming report, and capa.No ncs nor capas were identified in veeva.There were several complaints identified against this lot; however, with various failure modes.Therefore, this is not considered a trend.Devices met specification prior to release.
 
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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 Key19016095
MDR Text Key339082199
Report Number2125050-2024-00518
Device Sequence Number1
Product Code PAH
UDI-Device Identifier05701780274807
UDI-Public5701780274807
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K121562
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 04/01/2024
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 Number9066451_5196504022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/01/2024
Date Device Manufactured08/31/2023
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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