• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER, INC. HOLLISTER NEW IMAGE 2-PIECE OSTOMY SKIN BARRIER COLLECTOR, OSTOMY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HOLLISTER, INC. HOLLISTER NEW IMAGE 2-PIECE OSTOMY SKIN BARRIER COLLECTOR, OSTOMY Back to Search Results
Model Number 15603
Device Problems Fluid Leak (1250); Product Quality Problem (1506)
Patient Problem Exposure to Body Fluids (1745)
Event Date 02/14/2022
Event Type  Injury  
Event Description
Hollister ileostomy product; i have an ileostomy, the result of surgery for colon cancer. I had to change the flange (hollister model 15603) in the morning, but the adhesive portion of the flange began to peel away from my skin that evening, so it started to leak. In the end i had to change the flange again: that has never happened before, and i believe it indicates a serious quality problem with hollister. I have had the ileostomy for 26 years and in that time i have changed the flange hundreds of times. Never have i experienced such a problem. Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHOLLISTER NEW IMAGE 2-PIECE OSTOMY SKIN BARRIER
Type of DeviceCOLLECTOR, OSTOMY
Manufacturer (Section D)
HOLLISTER, INC.
MDR Report Key13549602
MDR Text Key285834855
Report NumberMW5107544
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeTH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model Number15603
Device Catalogue Number15603
Device Lot Number1C202
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 02/16/2022 Patient Sequence Number: 1
Treatment
BLOOD PRESSURE AND ; CHOLESTEROL MEDICINE; OSTOMY SUPPLIES
-
-