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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED POUCH, UROSTOMY (POUCH, UROSTOMY, NEW IMAGE H#18903 COLLECTOR, OSTOMY

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HOLLISTER INCORPORATED POUCH, UROSTOMY (POUCH, UROSTOMY, NEW IMAGE H#18903 COLLECTOR, OSTOMY Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Urticaria (2278); Blister (4537)
Event Date 12/16/2021
Event Type  Injury  
Event Description
Pt demonstrates definite allergy to both hollister hydrocolloid and hollister adhesive in the urostomy pouch. Symptoms: rash, urticaria pruritus, blister. Dates of use: (b)(6) 2021.
 
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Brand NamePOUCH, UROSTOMY (POUCH, UROSTOMY, NEW IMAGE H#18903
Type of DeviceCOLLECTOR, OSTOMY
Manufacturer (Section D)
HOLLISTER INCORPORATED
MDR Report Key13342577
MDR Text Key284479419
Report NumberMW5106921
Device Sequence Number1
Product Code NAD
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 01/20/2022
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received01/24/2022
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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