MAUDE Adverse Event Report: HOLLISTER INCORPORATED BARRIER, OSTOMY (BARRIER, OSTOMY, NEW IMAGE H#14603); COLLECTOR, OSTOMY

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Burning Sensation (2146)

Event Date 04/15/2021

Event Type  Injury  

Event Description

Pt was discharged in hollister ostomy products producing a red weeping burning rash that resolved when hollister was discontinued.Symptoms: skin rash, burning sensation.

• Brand Name: BARRIER, OSTOMY (BARRIER, OSTOMY, NEW IMAGE H#14603)
• Type of Device: COLLECTOR, OSTOMY
• Manufacturer (Section D): HOLLISTER INCORPORATED
• MDR Report Key: 12820610
• MDR Text Key: 280928483
• Report Number: MW5105352
• 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: 11/08/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• 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: 75 YR
• Patient Sex: Male