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

Catalog Number 14604

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 05/15/2022

Event Type  Injury  

Event Description

It was reported that an end user, who had been using hollister ostomy products for the last 10 years, started experiencing skin irritation under the ostomy barrier last month.She reported that her skin was red and warm to touch.She reported that she went to the ed who told her it was contact dermatitis.She reported that the ed gave her a pain shot, and antibiotics shot.She also reported she was sent home with a prescription for antibiotics and ascend silver sulfadiazine 1% cream for her irritated skin.End user reported that her skin has since improved but not completely.End user will trial other hollister ostomy products to see if that works better for her.

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 contact dermatitis to the barrier of the ostomy appliance cannot be determined.

• Brand Name: NEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT OSTOMY BARRIER
• Type of Device: NEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT OSTOMY 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: 14755645
• MDR Text Key: 294405423
• Report Number: 1119193-2022-00020
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 14604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 83 KG