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U.S. Department of Health and Human Services

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

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COLOPLAST A/S MANUFACTURING DORMIA DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number EXN9341002
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem Bacterial Infection (1735)
Event Date 03/04/2021
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 available information, though not verified, this patient experienced symptoms associated with pyelonephritis approximately 24 hours after the installation of this product for a lithotripsy procedure. The doctor noted that the cause of the infection could not be differentiated between this product, the installation procedure or how the patient cared for themselves post-procedure. It was reported that the patient was successfully treated with iv antibiotics.
 
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Brand NameDORMIA
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
COLOPLAST A/S MANUFACTURING
9 avenue edmond rostand
sarlat-la-caneda 24206
FR 24206
Manufacturer (Section G)
COLOPLAST A/S MANUFACTURING
9 avenue edmond rostand
sarlat-la-caneda 24206
FR 24206
Manufacturer Contact
usjki jennifer kinneman
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key11610845
MDR Text Key243939516
Report Number9610711-2021-00022
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K900269
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 04/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberEXN9341002
Device Catalogue NumberEXN934
Device Lot Number7561496
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/02/2021 Patient Sequence Number: 1
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