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

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.

• Brand Name: PREMIER
• Type of Device: COLLECTOR, OSTOMY
• Manufacturer (Section D): HOLLISTER INCORPORATED
• MDR Report Key: 12452630
• MDR Text Key: 271237590
• Report Number: MW5103817
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): Y
• 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: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR