MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE CERAPLUS CUT TO FIT BARRIER

Catalog Number 11702

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

Patient Problems Erythema (1840); Pain (1994)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

The lot number is not known so the device history record review is not possible.The device not saved for return so device evaluation not possible.The trend analysis conducted showed no adverse trends for skin irritation.The root cause of the sore skin and redness is not known.In addition, it is not known if the hollister barriers caused or contributed to this reported issue.

Event Description

It was reported that an end user has been experiencing skin irritation under the ostomy barrier since he got his stoma in (b)(6) 2020.He has used various brands of barriers and had a problem with all of them.He started using the hollister ceraplus barriers about 2 months ago and said he finds them the best of all with the least amount of skin irritation.He still does, however, experience occasional skin irritation.He describes his skin irritation as red, sore skin.No blisters or itching.Two months ago he was prescribed clobetasol propionate steroid spray by a wocn and instructed to use it only when necessary for the irritation.Over the past two months, he has only used it twice - with good results.He will continue to use the spray on an as-needed basis.

• Brand Name: NEW IMAGE CERAPLUS CUT TO FIT BARRIER
• Type of Device: NEW IMAGE CERAPLUS CUT TO FIT BARRIER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. 60048 3781
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville., IL 60048-3781 ; 8476802170
• MDR Report Key: 11365988
• MDR Text Key: 233081564
• Report Number: 1119193-2021-00010
• 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: Other
• Type of Report: Initial
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 11702
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 60