MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE SOFT CONVEX CERAPLUS CUT TO FIT BARRIER

Catalog Number 11703

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

Patient Problems Itching Sensation (1943); Urticaria (2278); Skin Inflammation/ Irritation (4545)

Event Date 04/20/2021

Event Type  Injury  

Event Description

It was reported that an end user started developing irritation under the tape border of her hollister ostomy barrier over a year ago.She described the irritation as red, scaly, sometimes open areas and itching.She saw her doctor at that time who prescribed clobetasol propionate topical preparation to apply to her skin under the tape at each appliance change.She reports that she has been using it regularly since.Now, she reports that she experiences this skin irritation under the tape border about 50% of the time.Hollister customer service is sending her other products to trial.

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 skin irritation under the tape border of barrier cannot be determined.

• Brand Name: NEW IMAGE SOFT CONVEX CERAPLUS CUT TO FIT BARRIER
• Type of Device: NEW IMAGE SOFT CONVEX CERAPLUS 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: 14209761
• MDR Text Key: 290094885
• Report Number: 1119193-2022-00012
• 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: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 11703
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2022
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 107 KG