MAUDE Adverse Event Report: COLOPLAST A/S 2PC URO MAXI TRANSP. 60 MM; UROSTOMY BAG

Model Number 0175901720

Device Problems Partial Blockage (1065); Improper or Incorrect Procedure or Method (2017)

Patient Problem Death (1802)

Event Type  Death  

Event Description

(b)(6).Date of event: best estimate (b)(6) 2015.According to the information received, it was reported that the outlet tube of a urostomy bag was blocked and urine could not be emptied from the bag.It was reported that the enduser was residing in an old person's home.The urostomy bag was changed by the family one morning and the family was contacted by the facility that the urine could not be emptied in the evening.The enduser's family came back to change the bag, however the timeframe was not specified.Three days after this event it was reported that the enduser had poor appetite.The enduser died 20 days later.During this period the enduser did not see a physician and no formal cause of death was determined.The family believed that the product problem caused a urinary tract infection which caused the death of the enduser.

Manufacturer Narrative

No formal cause of death was determined by a medical professional and the family will not speak with the company.As of to date no product was returned.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurence.Should additional information become available a follow-up report will be submitted.

• Brand Name: 2PC URO MAXI TRANSP. 60 MM
• Type of Device: UROSTOMY BAG
• Manufacturer (Section D): COLOPLAST A/S; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S; coloplast hungary kft; buzavirag ut 15; tatabanya, hu 2800 ; HU 2800
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6123024987
• MDR Report Key: 4654018
• MDR Text Key: 16544157
• Report Number: 3003814961-2015-00001
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/09/2018
• Device Model Number: 0175901720
• Device Catalogue Number: 0175901720
• Device Lot Number: 3566351
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/06/2015
• Initial Date FDA Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR