MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE CERAPLUS TAPE BORDER CUT TO FIT; OSTOMY BARRIER

Model Number 11203

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Fungal Infection (2419)

Event Date 04/01/2017

Event Type  Injury  

Manufacturer Narrative

No lot number or sample were provided.No indication by user that hollister barrier caused the yeast infection.

Event Description

It was reported by the user that approximately 2 weeks after she started to use the ceraplus barrier she developed pimples underneath the barrier.She went to her doctor who recommended an otc allergy relief.The rash continued to spread over her body.She then went to her primary care doctor who indicated it was a yeast infection and prescribed antifungal medication.Her stoma nurse also indicated a yeast infection and gave her an antifungal stoma powder.

• Brand Name: NEW IMAGE CERAPLUS TAPE BORDER CUT TO FIT
• Type of Device: OSTOMY BARRIER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister dr; libertyville IL 60048
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: anne riba ; 2000 hollister dr; libertyville, IL 60048 ; 8476805625
• MDR Report Key: 6579464
• MDR Text Key: 75599725
• Report Number: 1119193-2017-00023
• 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: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/21/2017,05/19/2017

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
• Device Operator: Lay User/Patient
• Device Model Number: 11203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Report to Manufacturer: 04/21/2017
• Initial Date Manufacturer Received: 04/21/2017
• Initial Date FDA Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 69