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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 5196502400
Device Problem No Apparent Adverse Event (3189)
Patient Problem Failure of Implant (1924)
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.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Device will not be returned.
 
Event Description
According to the available information, though not verified, reported complaint: "physician was beginning to tension altis when suture broke (dynamic anchor).Normal implantation and tensioning was completed.Broken altis was removed and new altis successfully implanted." product not returning.The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.
 
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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
usrll rachel lloyd
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key10988535
MDR Text Key221775110
Report Number2125050-2020-01247
Device Sequence Number1
Product Code PAH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/11/2020
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 Model Number5196502400
Device Catalogue Number519650
Device Lot Number7261727
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/12/2020
Initial Date FDA Received12/10/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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