MAUDE Adverse Event Report: HOLLISTER INCORPORATED BARRIER,OSTOMY (BARRIER,OSTOMY, NEW IMAGE H; COLLECTOR, OSTOMY

Model Number 14803

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 01/25/2021

Event Type  Injury  

Event Description

Pt using hollister barriers with chronic rash.Ostomy products have been switched to coloplas.Symptoms: rash, urticaria pruritus.

• Brand Name: BARRIER,OSTOMY (BARRIER,OSTOMY, NEW IMAGE H
• Type of Device: COLLECTOR, OSTOMY
• Manufacturer (Section D): HOLLISTER INCORPORATED
• MDR Report Key: 11384927
• MDR Text Key: 234011254
• Report Number: MW5099647
• 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: Nuclear Medicine Technologist
• Type of Report: Initial
• Report Date: 02/23/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 14803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR