MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE CONVEX FLEXTEND SKIN BARRIER WITH TAPE BORDER

Catalog Number 13903

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

Patient Problems Rash (2033); Skin Inflammation/ Irritation (4545)

Event Date 08/01/2021

Event Type  Injury  

Manufacturer Narrative

Lot number not provided so dhr review not possible.Sample not returned so sample evaluation not possible.Weight not provided so estimate used.The root cause of the skin irritation under the tape border of the barrier cannot be determined.

Event Description

It was reported that an end user started experiencing skin irritation under the tape border of the hollister ostomy barrier in april of this year.It was described as red and irritated.This irritation was not going away so he saw his dermatologist in august.The dermatologist gave him steroid injections under the skin and prescribed a steroid topical ointment.It was working well for him and the irritation was going away.When he stopped using the steroid ointment however, the irritation returned.When he called hollister it was suggested that he try a barrier without a tape border.Samples without a tape border have been sent to him to try.

• Brand Name: NEW IMAGE CONVEX FLEXTEND SKIN BARRIER WITH TAPE BORDER
• Type of Device: NEW IMAGE CONVEX FLEXTEND SKIN BARRIER WITH TAPE BORDER
• 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: 12657795
• MDR Text Key: 277175202
• Report Number: 1119193-2021-00032
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 13903
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2021
• 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: 58 YR
• Patient Weight: 68