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

Model Number 15603

Device Problems Fluid/Blood 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).

• Brand Name: HOLLISTER NEW IMAGE 2-PIECE OSTOMY SKIN BARRIER
• Type of Device: COLLECTOR, OSTOMY
• Manufacturer (Section D): HOLLISTER, INC.
• MDR Report Key: 13549602
• MDR Text Key: 285834855
• Report Number: MW5107544
• Device Sequence Number: 1
• Product Code: EXB
• UDI-Device Identifier: 00610075156030
• UDI-Public: (01)00610075156030(17)260301(30)
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• 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 Received: 02/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 15603
• Device Catalogue Number: 15603
• Device Lot Number: 1C202
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: BLOOD PRESSURE AND ; CHOLESTEROL MEDICINE; OSTOMY SUPPLIES
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White