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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S DORMIA DISLODGER, STONE, BASKET, URETERAL, METAL

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COLOPLAST A/S DORMIA DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number EXN4341002
Device Problems Fracture (1260); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2020
Event Type  malfunction  
Manufacturer Narrative
Visual examination of the returned device confirmed the sheath was broken at the top near the basket.
 
Event Description
According to the available information, during the procedure, one of the catheter¿s ¿handle¿ broke and detached from the device. A foreign body was in the ureter; another dormia was used to fetch the detached piece.
 
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Brand NameDORMIA
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
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
usauv autumn valentine
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key11195537
MDR Text Key227791920
Report Number9610711-2021-00011
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial
Report Date 01/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEXN4341002
Device Catalogue NumberEXN434
Device Lot Number7179912
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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