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

Model Number 11204

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Itching Sensation (1943)

Event Date 07/09/2016

Event Type  Injury  

Manufacturer Narrative

Biocompatibility testing has been performed in accordance with is0 10993 and materials were found to be non-sensitizers.

Event Description

It was reported by the user that following her ostomy surgery she was placed in the new image cera plus barrier.Almost immediately localized redness was noticed under the tape portion of the barrier.On (b)(6) the itching under the tape portion of the barrier increased but the user felt it was due to the hot weather and sweating.Hives and itching spreading out from the tape area and moving to her legs was noticed on (b)(6).She had no trouble breathing or other symptoms.The next day she saw a dermatologist who prescribed steroid cream and otc antihistamine.On (b)(6) her ostomy nurse switched her to a different company's non-tape product and suggested she go to the er for the hives since they were not improving.She received iv benadryl and oral steroids in the er.By (b)(6) the hives were almost gone and the itching had ceased resulting in her feeling much better.

• 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: 5872803
• MDR Text Key: 52002003
• Report Number: 1119193-2016-00020
• 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: 07/15/2016,08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 11204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Report to Manufacturer: 07/15/2016
• Date Manufacturer Received: 07/15/2016
• 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; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 66