MAUDE Adverse Event Report: HOLLISTER INCORPORATED CONFORM 2 CONVEX CUT TO FIT TAPE BORDERED BARRIER

Catalog Number 35400

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

Patient Problem Rash (2033)

Event Date 06/15/2021

Event Type  Injury  

Manufacturer Narrative

Patient's weight not known so estimate used.No lot number or samples provided so dhr review and sample evaluation is not possible.A review of hollister's post market complaint database shows no other complaints of skin irritation for this product over the last 3 years.A review of the product risk assessment shows that the harm of skin irritation associated with the use of hollister's barrier products is present the risks are being reduced to the extent possible and this conclusion remains unchanged.The root cause of the reported skin irritation cannot be determined.Hollister will continue to track and trend the performance of the barrier in our post market complaint system.

Event Description

This report is for the fourth of seven patients reported through the same distributor who experienced skin irritation.It was reported that an end user experienced skin irritation under the hollister ostomy barrier.The irritation began 2 months after they started using the barrier.The patient saw an ostomy nurse and their family physician who prescribed dermacombin (which is a combination of neomycin sulfate, gramicidin, nystatin and triamcinolone acetonide cream), and hydroagisten cream (clotrimazole 1% and hydrocortisone acetate 1%).This is suspected to be an allergic reaction.The irritation has partially improved.

• Brand Name: CONFORM 2 CONVEX CUT TO FIT TAPE BORDERED BARRIER
• Type of Device: CONFORM 2 CONVEX CUT TO FIT TAPE BORDERED BARRIER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. 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: 12301817
• MDR Text Key: 265839874
• Report Number: 1119193-2021-00024
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 35400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 68