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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S DRM 4 HEL W/O FILIF CH2.5 120 URETERAL STONE DISLODGER

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COLOPLAST A/S DRM 4 HEL W/O FILIF CH2.5 120 URETERAL STONE DISLODGER Back to Search Results
Model Number DOR6341002
Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Type  Injury  
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 facts 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.
 
Event Description
According to the available information, during a kidney stone extraction procedure, the device was not working. Despite a positive test before use, it did not work during the procedure. This defect doubled the procedure time and resulted in incomplete extraction of kidney stones. Therefore, the patient will have a new intervention.
 
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Brand NameDRM 4 HEL W/O FILIF CH2.5 120
Type of DeviceURETERAL STONE DISLODGER
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, 3050
DA 3050
Manufacturer (Section G)
COLOPLAST A/S MANUFACTURING FRANCE
9 avenue edmond rostand
sarlat-la-caneda, 24206
FR 24206
Manufacturer Contact
sarah o'gara
1601 west rivier road north
minneapolis,, MN 55411
6123578517
MDR Report Key8268686
MDR Text Key133788219
Report Number9610711-2019-00003
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 03/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDOR6341002
Device Catalogue NumberDOR634
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/22/2019 Patient Sequence Number: 1
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