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U.S. Department of Health and Human Services

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

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HOLLISTER INCORPORATED BARRIER,OSTOMY (BARRIER,OSTOMY, NEW IMAGE H COLLECTOR, OSTOMY Back to Search Results
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.
 
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Brand NameBARRIER,OSTOMY (BARRIER,OSTOMY, NEW IMAGE H
Type of DeviceCOLLECTOR, OSTOMY
Manufacturer (Section D)
HOLLISTER INCORPORATED
MDR Report Key11384927
MDR Text Key234011254
Report NumberMW5099647
Device Sequence Number1
Product Code EXB
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
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  
0 Patients were Involved in the Event:
Date FDA Received02/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number14803
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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