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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#14603) COLLECTOR, OSTOMY

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HOLLISTER INCORPORATED BARRIER, OSTOMY (BARRIER, OSTOMY, NEW IMAGE H#14603) COLLECTOR, OSTOMY Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Rash (2033); Burning Sensation (2146)
Event Date 04/15/2021
Event Type  Injury  
Event Description
Pt was discharged in hollister ostomy products producing a red weeping burning rash that resolved when hollister was discontinued. Symptoms: skin rash, burning sensation.
 
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Brand NameBARRIER, OSTOMY (BARRIER, OSTOMY, NEW IMAGE H#14603)
Type of DeviceCOLLECTOR, OSTOMY
Manufacturer (Section D)
HOLLISTER INCORPORATED
MDR Report Key12820610
MDR Text Key280928483
Report NumberMW5105352
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 11/08/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received11/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes

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