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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC ALTIS SINGLE INCISION SLING SYSTEM; SURGICAL MESH
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COLOPLAST MANUFACTURING US, LLC ALTIS SINGLE INCISION SLING SYSTEM; SURGICAL MESH Back to Search Results
Model Number 5196502400
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  malfunction  
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.Once our evaluation is complete, a follow-up report will be submitted.
 
Event Description
As reported to coloplast though not verified, medwatch - (b)(4): the anchor broke while being placed.A piece of the anchor broke off and left behind.The surgeon had to use another complete sling system.
 
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Brand Name
ALTIS SINGLE INCISION SLING SYSTEM
Type of Device
SURGICAL MESH
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
usrll rachel lloyd
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key10789260
MDR Text Key214774658
Report Number2125050-2020-01051
Device Sequence Number1
Product Code PAH
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 Other Health Care Professional
Type of Report Initial
Report Date 11/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5196502400
Device Catalogue Number519650
Device Lot Number6862413
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/06/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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