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

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.

• Brand Name: POUCH, UROSTOMY (POUCH, UROSTOMY, NEW IMAGE H#18903
• Type of Device: COLLECTOR, OSTOMY
• Manufacturer (Section D): HOLLISTER INCORPORATED
• MDR Report Key: 13342577
• MDR Text Key: 284479419
• Report Number: MW5106921
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• 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
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male