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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 EXT6241002
Device Problems Fracture (1260); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/28/2021
Event Type  malfunction  
Event Description
According to the available information, during testing prior to use, the basket opened from the side, appearing warped, bent, crooked and unusually misshapen. When the physician attempted to use the device, the basket wires broke. The device was changed and there was no harm to the patient.
 
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 the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
 
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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
usaby angela kilian
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key13338488
MDR Text Key288288637
Report Number9610711-2022-00004
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,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEXT6241002
Device Catalogue NumberEXT624
Device Lot Number8001207
Was Device Available for Evaluation? No
Date Manufacturer Received01/13/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/19/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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