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

Catalog Number 14803

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

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

Event Date 04/08/2022

Event Type  Injury  

Manufacturer Narrative

Trend analysis conducted and no adverse trends observed over the last 3 years.Lot number provided.Device history records reviewed and found to be complete and accurate.Sample not returned so sample evaluation not possible.Root cause of reported skin irritation, blisters, and redness under the barrier and beyond cannot be determined.Hollister is sending samples of a different hollister skin barrier for the end user to try.

Event Description

It was reported that an end user experienced pain and redness on her skin after removing her hollister ostomy extended wear barrier that had only been in place for several hours.She reported that the barrier was difficult to remove.She reported that she applied a new barrier but needed to remove it later that day because her skin was burning and itching.She reported that again was difficult to remove and when she removed the barrier, there were blisters and redness on her skin that extended beyond the edges of the barrier.She reported she went to her doctor the next day who said she may be experiencing an allergic reaction, although no allergy testing was done.She reported he prescribed clotrimazole betamethasone (antifungal & corticosteroid) cream to treat the affected area.She said she is seeing slight improvement already.Hollister is sending different barrier products for her to try.

• Brand Name: NEW IMAGE CONVEX FLEXTEND CUT TO FIT OSTOMY BARRIER
• Type of Device: NEW IMAGE CONVEX FLEXTEND 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: 14209774
• MDR Text Key: 290084943
• Report Number: 1119193-2022-00010
• 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: 14803
• Device Lot Number: 1F252
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2022
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 79 KG