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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED POUCH, OSTOMY (POUCH, DRAINABLE, PREMIER H#8551) COLLECTOR, OSTOMY

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HOLLISTER INCORPORATED POUCH, OSTOMY (POUCH, DRAINABLE, PREMIER H#8551) COLLECTOR, OSTOMY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Rash (2033); Swelling (2091)
Event Date 09/22/2020
Event Type  Injury  
Event Description
Symptoms: rash, erythema multiform, blister. Suspect drug dosing: use pouch as directed - for ostomy care. Treatment drugs used: adhesive remover (adhesive remover liquid). Diagnosis for use: ostomy supply.
 
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Brand NamePOUCH, OSTOMY (POUCH, DRAINABLE, PREMIER H#8551)
Type of DeviceCOLLECTOR, OSTOMY
Manufacturer (Section D)
HOLLISTER INCORPORATED
MDR Report Key10650111
MDR Text Key210631708
Report NumberMW5097147
Device Sequence Number1
Product Code EXB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 10/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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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