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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED PREMIER COLLECTOR, OSTOMY

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HOLLISTER INCORPORATED PREMIER COLLECTOR, OSTOMY Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Blister (4537); Skin Inflammation/ Irritation (4545)
Event Date 06/30/2021
Event Type  No Answer Provided  
Event Description
Pt found to have moderate reaction to hollister urostomy pouch with red open weeping rash and formation of large open peristomal wound. Symptoms: skin rash, urticaria pruritus, blister.
 
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Brand NamePREMIER
Type of DeviceCOLLECTOR, OSTOMY
Manufacturer (Section D)
HOLLISTER INCORPORATED
MDR Report Key12452630
MDR Text Key271237590
Report NumberMW5103817
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 Pharmacist
Type of Report Initial
Report Date 09/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
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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