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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 Name
DORMIA
Type of Device
DISLODGER, 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
1 Patient was 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 Health Professional
Device Model NumberEXN4341002
Device Catalogue NumberEXN434
Device Lot Number7179912
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2021
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 Unknown
Patient Sequence Number1
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