HOLLISTER 3228 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-09-18 for HOLLISTER 3228 * manufactured by Hollister Inc.

Event Text Entries

[18555410] Rptr lost their colon and rectum to ulcerative colitis. Rptr has been wearing hollister product #3228 for twenty-two (22) years. Rptr has always been very active. Rptr was one of the top mile and cross country runners in the state during high school. Rptr would have pursued sports in college, had they not gotten sick. Rptr has noticed a marked decline in the quality of the plastic used in #3228 during the last ten (10) years, approximately. Since that time the bag has developed small cracks and holes which allow fecal matter to leak on clothes and legs. Plus you have the odor of fecal matter in the air to go along with the mess. From 1978 until about 1990, #3228 never got cracks and holes in it. The reason for changing the bag would always be due to the seal failing after three (3) to five (5) days (which is normal). Rptr used to work in the tobacco fields. No matter what rptr did the bag held strong and never got stress cracks and holes in it. Rptr would come home and find the bag to be stretched and deformed from resting large bundles of tobacco sticks on their leg as they walked down the rows depositing a stick at every 6 plants. The bags they make now would not have made it to the first "little debbie" snack time at 10:00 am before rptr would have feces all over their leg. Now rptr can't ride a bike, take a long hike, or anything physically active for more than a few hrs before they get feces on leg. Then they have to stop what they are doing, find a place to clean up, and fix the bag with duct tape. Rptr used to take one (1) bag with them on a three (3) day camping trip, just in case. Now rptr takes three (3) bags, comes home wearing the third bag and it is full of tape. Rptr has only complained a few times in the last ten (10) years. The first two (2) or three (3) times rptr called rptr was very nice and the rep on the phone denied any knowledge or understanding of any problem. They simply wanted to send rptr a free box of replacement bags. About a year went by between each time rptr complained. About two (2) years ago rptr left a very stern message on their answering machine as to rptr's dissatisfaction with their product. A lady who said she was in charge of quality control reluctantly admitted having knowledge of problem. Rptr asked her point blank if the plastic was made in house. She said no but she did not want to tell rptr who they purchased the plastic from. She assured rptr that their complaint was not falling on deaf ears and that she would inform rptr of any progress in getting the bag fixed. Rptr never heard from her again. After another year, rptr sent a stern e-mail followed by an after hour message on their answering machine. Rptr still has not heard from brass, as rptr so sternly demanded. Rptr also started a message campaign stating the problems they have been having. Rptr has only found two (2) other individuals having the same problems. Rptr has demanded to talk to officers of the co, but so far they have not heard from them. A rep did call rptr about ten (10) days ago and swore to rptr that according to a twenty (20) years employee in their mfg facility that nothing has been changed in the mfg process. Rptr is assuming that most of the people that wear ostomy bags are a lot older and far less active than rptr. This problem is directly related to physical activity. About a year ago rptr had a consultation and met with a nurse and salesman. The nurse was familiar with hollister #3228 and stated that the plastic had been reduced from eleven (11) ply to four (4) ply. Rptr has tried a different product from hollister, #3608. It seems to be a lot better, but not up to par. Update: labor day weekend in 2001, rptr just had their first three day camping trip in which they were wearing the same bag when they got home that they left home with (#3608), in at least ten years. The #3228 that rptr removed prior to leaving had several small holes in it after thirty hours of use. The #3608 rptr wore home was on a total of five full days which is when the seal failed (normal). It is imperative that rptr find out why #3228 is junk, so rptr can see to it that #3608 does not become "junk" as well. Rptr believes that there needs to be government intervention in setting colostomy bag standards.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1022880
MDR Report Key352292
Date Received2001-09-20
Date of Report2001-08-25
Date Added to Maude2001-09-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameHOLLISTER
Generic NamePRODUCT #3228 (OSTOMY BAG)
Product CodeFON
Date Received2001-09-18
Model Number3228
Catalog Number*
Lot NumberWITHIN THE LAST
ID Number10-12 YEARS
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key341570
ManufacturerHOLLISTER INC
Manufacturer Address2000 HOLLISTER DRIVE LIBERTYVILLE IL 600483781 US


Patients

Patient NumberTreatmentOutcomeDate
10 2001-09-20

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