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

Model Number 11204

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

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Skin Discoloration (2074); Skin Inflammation (2443)

Event Date 08/17/2016

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 in (b)(6) 2016 she had colostomy surgery related to ovarian cancer.She developed redness under the barrier portion of her ostomy products.She switched to the new image ceraplus barrier on (b)(6) 2016.The first ceraplus barrier was on for 7 days and when she removed it she found the skin under the barrier to be very red and painful.She reported there was no leakage during this time.She applied two more ceraplus barriers and removed them daily but the reddened area worsened.She believes the edge of the barrier may also have been rubbing against her stoma causing some bleeding.She went to the doctor on (b)(6) and was prescribed septra and flagyl for the skin condition.She noted improvement.User is on chemotherapy which has decreased her immunity resulting in numerous infections in different parts of her body.

• 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: 6010592
• MDR Text Key: 56790887
• Report Number: 1119193-2016-00022
• 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: 09/12/2016,10/07/2016

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: 11204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Report to Manufacturer: 09/12/2016
• Initial Date Manufacturer Received: 09/12/2016
• Initial Date FDA Received: 10/07/2016
• 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): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 60