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

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.

Manufacturer Narrative

Additional information has been added to the "report incident description" concluding in annex f being updated with an additional code.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

On the (b)(6) 2021 the patient confirmed that the blockage and the presence of the bacteria in the bladder led to the sepsis.As the consequence of the incident, the patient was hospitalized for 7 days and and required treatment with vancomycin by intravenous drip an then oral antibiotic.

• Brand Name: SENSURA MIO CLICK UROSTOMY POUCH
• Type of Device: MIO 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 Key: 12598156
• MDR Text Key: 275401173
• Report Number: 3003814961-2021-00003
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• PMA/PMN Number: E278842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• 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 Received: 10/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1149701003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Sex: Female