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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED PREMIER H8483 COLLECTOR, OSTOMY

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HOLLISTER INCORPORATED PREMIER H8483 COLLECTOR, OSTOMY Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Itching Sensation (1943); Rash (2033); Urticaria (2278)
Event Date 08/20/2021
Event Type  No Answer Provided  
Event Description
History and current ostomy management: pt was managing in hollister pre-cut pouch #(b)(4), but continued to have peristomal rash. He was issued dakin solution for cleaning, then triamcinolone spray, and lastly thin hydrocolloid to block the reaction from the hollister barrier. This seems to have worked, and so updated allergy list to include hollister barriers. Pt was switched to coloplast formulary urostomy pouches with some success. Symptom: rash, urticariapruritus.
 
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Brand NamePREMIER H8483
Type of DeviceCOLLECTOR, OSTOMY
Manufacturer (Section D)
HOLLISTER INCORPORATED
MDR Report Key12532394
MDR Text Key273674813
Report NumberMW5104192
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 09/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2021
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
Is This a Reprocessed and Reused Single-Use Device?

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