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

Model Number 14803

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

Patient Problems Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 11/28/2022

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 what she reported to be an allergic reaction to the hollister new image barrier.She said that her skin itches.She said she has used this product for 3 to 4 years and has not been able to resolve the itchiness.She reported that she saw her doctor who provided her with a prescription for triamcinolone acetonide cream.Hollister is sending her samples of a different formulation of new image barrier 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: 15968494
• MDR Text Key: 305336812
• Report Number: 1119193-2022-00039
• Device Sequence Number: 1
• Product Code: EXB
• UDI-Device Identifier: 20610075148039
• UDI-Public: 00610075148035
• 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: 12/13/2022

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 Model Number: 14803
• Device Catalogue Number: 14803
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/13/2022
• 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: 71 YR
• Patient Sex: Female