MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER

Catalog Number 11203

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

Patient Problem Skin Irritation (2076)

Event Date 01/29/2019

Event Type  Injury  

Manufacturer Narrative

Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers.Dhr review conducted and no issues identified.Sample review not possible because no sample available.Trend data reviewed and no adverse trend observed.Root cause of this reported issue cannot be determined.

Event Description

It was reported that the end user had colostomy surgery on (b)(6) 2018 and started having skin irritation under the new image ostomy barrier in (b)(6) 2019.She saw her dermatologist numerous times and was prescribed nystatin fungal powder on (b)(6) 2019 and clobetasol steroid cream on (b)(6) 2019 to address the irritation.Neither completely worked.She is now experiencing weepy skin below the stoma.She is using a liquid skin barrier with some relief.The doctor said that her skin issues may be related to her ulcerative colitis.She will continue to work with her visiting nurse to see if other barrier samples help her skin.

• Brand Name: NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER
• Type of Device: NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville, il
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft, va
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville., ; 6802170
• MDR Report Key: 9780830
• MDR Text Key: 187619318
• Report Number: 1119193-2020-00004
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 11203
• Device Lot Number: 0A132
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 64