MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT BARRIER

Catalog Number 14803

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 12/18/2020

Event Type  Injury  

Manufacturer Narrative

Trend analysis conducted and no adverse trends observed.Lot number not provided so device history records could not be reviewed.Sample not returned so sample evaluation not possible.Root cause of reported irritation under the ostomy barrier and tape border cannot be determined.

Event Description

It was reported that an end user developed skin irritation under the hollister new image ostomy barrier approximately 1 ½ years ago.She was told it was a yeast infection which became septic and she was hospitalized.She reported that the skin irritation has never gone away fully.She reports now having blisters on the skin and it is very itchy.She states this is under both the barrier and the tape border of the barrier.She reports she was prescribed miconazole which did not work fully so she was recently prescribed betamethasone and clotrimazole ointment.She reports that is helping.She reports having an allergy to adhesives.Hollister customer service is sending her samples of ceraplus barriers for her to try.

• Brand Name: NEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT BARRIER
• Type of Device: NEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT BARRIER
• Manufacturer (Section D): HOLLISTER INCROPORATED; 2000 hollister drive; libertyville IL 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: 14490290
• MDR Text Key: 292580692
• Report Number: 1119193-2022-00019
• 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: 05/24/2022

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 Catalogue Number: 14803
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 05/24/2022
• 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: 69 YR
• Patient Sex: Female