FDA Adverse Event Death Summary report: N

2PC URO MAXI TRANSP. 60 MM

MDR report key: 4654018 · Received April 2, 2015

Report

Report Number: 3003814961-2015-00001
Event Type: Death
Date Received: April 2, 2015
Report Date: March 6, 2015
Manufacturer: COLOPLAST A/S
Product Code: EXB
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

(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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
217056	2PC URO MAXI TRANSP. 60 MM	UROSTOMY BAG	EXB	COLOPLAST A/S	0175901720	3566351

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR		Death