MAUDE Adverse Event Report: HOLLISTER INC. FLEX WEAR OSTOMY SKIN BARRIER; COLLECTOR, OSTOMY

Model Number 14206

Device Problems Leak/Splash (1354); Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Date 06/03/2022

Event Type  malfunction  

Event Description

I was in a public place when my ostomy apparatus breached meaning it started leaking when i was out in a public place, heralded by the tell-tell odor of (b)(6).I had to drop what i was doing and go home immediately.Ostomy supplies (barriers wafers) from hollister have become so thinned and reduced hat they have become ineffective.I am having to change the bag every other day now because they keep breaching due to the thinning out of the ostomy materials.My compliant the materials used to make skin hollister two-part ostomy unit has suffered am extreme reduction in quality and effectiveness.The drainable pouches and skin barrier wafers have been reduced to a thinness that makes the ostomy device ineffective and prone to excessive embarrassing leaks, breaches and odors.The drainable pouches and the skin barrier wafers are both composed of fabric and plastic.The fabric and the plastic in both have become so thin that the pouch contents are seeping through the thin fabric (of the pouch) where it meets the hard plastic o- ring.Also, the thin fabric of the skin barrier wafer is also seeping through or breaching where the fabric meets the o-ring, even as it¿s attached to me.These leaks and breaches are very upsetting and very embarrassing when they happen in a public place.I started using these hollister ostomy bags in 2012.They were so good then.I could wear them for 8,9,10 days back then.Without odors, breaches or leaks.Then in 2017, average days of usage went down to about 6-7 days.In 2018, it dropped again to about 4-5 average days of usage.It remained roughly, at that level until l2022.In 2022, the bags started becoming odors and/ or breaching or leaking after 2-3 days of usage.Then i noticed how thin the fabric and plastic and skin barriers from years before, so i pulled some out to compare.The materials used to produce the current ostomy units have become so thinned out, compared to what they were that it¿s little wonder that the bags rare smelling, breaching and leaking so quickly.I am now having to change these bags every other day.I have been keeping records to my bag changes since i stared using those hollister bags, so i can look at them and see how these bags have changed over the years.Another part of the unit that has been thinned down and is causing problems is the plastic lip of the drainable pouch where the bag contents are emptied.It has gotten so thin that it flaps backup when contents are being emptied, necessitating the use of a finger to push it back down to allow the contents to continue to flow.Definitely a yuk factor.The lips of these bags didn't use to do that.I hope you can investigate why hollister has so reduced the quality and effectiveness of their ostomy system.They certainly haven't reduced the price of the product, not to medicare or myself.I feel like i am in the middle of a fraud.Thank you for your services.

• Brand Name: FLEX WEAR OSTOMY SKIN BARRIER
• Type of Device: COLLECTOR, OSTOMY
• Manufacturer (Section D): HOLLISTER INC.
• MDR Report Key: 14874671
• MDR Text Key: 295222444
• Report Number: MW5110618
• Device Sequence Number: 1
• Product Code: EZP
• 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
• Type of Report: Initial
• 4 Devices were Involved in the Event: 1 2 3 4

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: 14206
• Device Lot Number: 1J052
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2022
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN 40 MG/DAY; LISINOPRIL 20 MG/DAY; LOCK N-ROLL DRAINABLE OSTOMY POUCH; METFORMIN HCL 500 MG AT 4/DAY ; MULTIVITAMIN 1/DAY ; OSTOMY SKIN BARRIER
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American