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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S BIOSOFT DUO DOUBLE LOOP STENT; STENT, URETERAL
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COLOPLAST A/S BIOSOFT DUO DOUBLE LOOP STENT; STENT, URETERAL Back to Search Results
Model Number BNAA751002
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
According to the available information, a hair was sealed in the unopened package.Therefore, the device was no longer sterile.
 
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 information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.
 
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Brand Name
BIOSOFT DUO DOUBLE LOOP STENT
Type of Device
STENT, URETERAL
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebæk 3050
DA  3050
Manufacturer (Section G)
COLOPLAST A/S MANUFACTURING
9 avenue edmond rostand
sarlat-la-caneda 24206
FR   24206
Manufacturer Contact
usbes brian e schmidt
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key17088378
MDR Text Key317732093
Report Number9610711-2023-00114
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
PMA/PMN Number
K170422
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/08/2023
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 NumberBNAA751002
Device Catalogue NumberBNAA75
Device Lot Number9055680
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/01/2023
Initial Date FDA Received06/08/2023
Date Device Manufactured02/27/2023
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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