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

Model Number 14604

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 12/15/2020

Event Type  Injury  

Event Description

Pt developed "runaway rash" when using hollister barriers after a fall.Symptoms: skin 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: 11384921
• MDR Text Key: 234009604
• Report Number: MW5099646
• 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: 02/23/2021

1 Device was Involved in the Event

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: 14604
• 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: 77 YR