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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 EXN9341002
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/16/2021
Event Type  malfunction  
Manufacturer Narrative
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, the inner packaging was missing the label. The hospital received the item in the retail box, which did have a label; however, they opened the retail box to bring just the ¿primary package¿ into the operating room. At that point, the issue was identified.
 
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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 Key11821313
MDR Text Key260731420
Report Number9610711-2021-00039
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
PMA/PMN Number
K900269
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial
Report Date 05/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEXN9341002
Device Catalogue NumberEXN934
Device Lot Number7708279
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/13/2020
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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