MAUDE Adverse Event Report: HOLLISTER INCORPORATED POUCH,UROSTOMY,PREMIER H#8478; COLLECTOR, OSTOMY

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 03/22/2023

Event Type  Injury  

Event Description

10037087: pruritus, 10037844: rash, 10069327: product quality issue.Pt using hollister urostomy pouch with rash and itching and constant leaking.Skin is resolved with use of coloplast products.

• Brand Name: POUCH,UROSTOMY,PREMIER H#8478
• Type of Device: COLLECTOR, OSTOMY
• Manufacturer (Section D): HOLLISTER INCORPORATED
• MDR Report Key: 18066867
• MDR Text Key: 327477729
• Report Number: MW5147745
• Device Sequence Number: 1
• Product Code: EXB
• 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: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male