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

Model Number	15603
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: COLLECTOR, OSTOMY
• Manufacturer (Section D): HOLLISTER, INC.
• MDR Report Key: 13549602
• Report Number: MW5107544
• Device Sequence Number: 14407546
• Product Code: EXB
• UDI-Device Identifier: 00610075156030
• UDI-Public: (01)00610075156030(17)260301(30)
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BLOOD PRESSURE AND ; CHOLESTEROL MEDICINE; OSTOMY SUPPLIES
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White