MAUDE Adverse Event Report: HOLLISTER INCORPORATED PREMIER H8483; COLLECTOR, OSTOMY

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033); Urticaria (2278)

Event Date 08/20/2021

Event Type  No Answer Provided  

Event Description

History and current ostomy management: pt was managing in hollister pre-cut pouch #(b)(4), but continued to have peristomal rash.He was issued dakin solution for cleaning, then triamcinolone spray, and lastly thin hydrocolloid to block the reaction from the hollister barrier.This seems to have worked, and so updated allergy list to include hollister barriers.Pt was switched to coloplast formulary urostomy pouches with some success.Symptom: rash, urticariapruritus.

• Brand Name: PREMIER H8483
• Type of Device: COLLECTOR, OSTOMY
• Manufacturer (Section D): HOLLISTER INCORPORATED
• MDR Report Key: 12532394
• MDR Text Key: 273674813
• Report Number: MW5104192
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2021
• Patient Sequence Number: 1
• Patient Age: 72 YR