MAUDE Adverse Event Report: HOLLISTER INCORPORATED POUCH, OSTOMY (POUCH, DRAINABLE, NEW IMAGHE H# 18193); COLLECTOR, OSTOMY

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Erythema (1840)

Event Date 09/07/2021

Event Type  No Answer Provided  

Event Description

Erythema now observed after using hollister products twice after two different surgeries.Symptoms: erythema.Dates of use: (b)(6) 2012- (b)(6) 2021.

• Brand Name: POUCH, OSTOMY (POUCH, DRAINABLE, NEW IMAGHE H# 18193)
• Type of Device: COLLECTOR, OSTOMY
• Manufacturer (Section D): HOLLISTER INCORPORATED
• MDR Report Key: 12481599
• MDR Text Key: 272533756
• Report Number: MW5104019
• 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: 09/13/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• 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: 75 YR