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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 BCAGE41002
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/23/2021
Event Type  malfunction  
Event Description
According to the available information, there was a hair in the screw thread.
 
Manufacturer Narrative
Lot number: 7956517.
 
Manufacturer Narrative
After receiving this complaint, a search was performed for other complaints from the same lot and none were found.Checking the quality databases revealed no anomaly in connection with the described defect.On the sample received, no foreign material, such as hair was observed.
 
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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
usaby angela kilian
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key13792733
MDR Text Key287923854
Report Number9610711-2022-00037
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
PMA/PMN Number
K013921
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,Followup
Report Date 05/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBCAGE41002
Device Catalogue NumberBCAGE4
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/28/2022
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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