MAUDE Adverse Event Report: HOLLISTER INCORPORATED HOLLISTER OSTOMY BAG COLLECTION SYSTEM; COLLECTOR, OSTOMY

Model Number 18004

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

My daughter has colorectal cancer and has had part of the colon and intestine removed which has necessitated a temporary resection to the front of her abdomen.She is prescribed the hollister ostomy bag system to collet human feces, this will remain so until she receives chemo and the resection can be reversed, the hollister collection fails completely about 80 of the time resulting in human feces all over my daughter her cloths and what ever is near requiring a shower and a massive cleanup.Conversations with hollister have customer service have resulted in a change in some of the hollister devices use, but have failed miserably.I come from the medical device field (b)(4) and i know that an entry like this in our customer complaint file would have resulted in an immediate investigation and if substantiated would result is severe penalties.I don't know how it works now as i have been retired from (b)(4) for some years.My daughter is covered with human crap usually at least once a day.Entirely due to the hollister ostomy bag system that doesn't work.Photographs can be supplies but my daughter is asleep trying to recover from the latest exploded bag, she will then have to clean up herself, change all the bed linens.Place her cloths in the wash and get ready for the next failure."two piece drainable ostomy." fda safety report id # (b)(4.

• Brand Name: HOLLISTER OSTOMY BAG COLLECTION SYSTEM
• Type of Device: COLLECTOR, OSTOMY
• Manufacturer (Section D): HOLLISTER INCORPORATED
• MDR Report Key: 13928731
• MDR Text Key: 288171152
• Report Number: MW5108526
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 18004
• Device Lot Number: 1K042
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: White