MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE, CUT TO FIT; OSTOMY BARRIER

Model Number 14803

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Rash (2033); Fungal Infection (2419)

Event Date 10/01/2016

Event Type  Injury  

Manufacturer Narrative

The user is currently taking humira and patients treated with this are at an increased risk for developing infections.Her doctor feels this is a contributing factor to her condition.

Event Description

It was reported by the patient, that she developed a recurring red, itchy rash under the barrier and tape portion of the appliance.The rash oozes making it difficult for her pouch to stick.The doctor is treating it as a yeast infection with nystatin powder but it never completely clears up.The doctor thinks the irritated area may be due to the medication she is on.She also stated that she had the issue with her skin prior to her ostomy surgery and it went away while she was in the hospital.

• Brand Name: NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE, 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: 6621358
• MDR Text Key: 76953198
• Report Number: 1119193-2017-00025
• 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: 05/11/2017,06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 14803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Report to Manufacturer: 05/11/2017
• Date Manufacturer Received: 05/11/2017
• 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: 37 YR
• Patient Weight: 44