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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S SENSURA MIO CLICK UROSTOMY POUCH MIO CLICK URO MX 50MM

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COLOPLAST A/S SENSURA MIO CLICK UROSTOMY POUCH MIO CLICK URO MX 50MM Back to Search Results
Model Number 1149701003
Device Problem Insufficient Information (3190)
Patient Problem Septic Shock (2068)
Event Date 09/13/2021
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
It was reported to coloplast that there was an incident with the involvement of sensura mio click urostomy bag. Following the information collected, the bag became twisted, causing the urine not to flow properly into the bag. The end user sustained urinary reflux that led to a septic shock. The relationship between the patient's sepsis and the reported bag malfunction yet remains unknown. No additional information was provided.
 
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Brand NameSENSURA MIO CLICK UROSTOMY POUCH
Type of DeviceMIO CLICK URO MX 50MM
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebæk 3050
DA 3050
Manufacturer (Section G)
COLOPLAST HUNGARY - NYI
coloplast utca 2
nyírbátor 4300
HU 4300
Manufacturer Contact
usmaco maria bosse
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key12598156
MDR Text Key275401173
Report Number3003814961-2021-00003
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
PMA/PMN Number
E278842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1149701003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/06/2021
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 Initial

Patient Treatment Data
Date Received: 10/08/2021 Patient Sequence Number: 1
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