MAUDE Adverse Event Report: HOLLISTER INCORPORATED FLEXTEND BARRIERS WITH TAPE BORDER; OSTOMY

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

Patient Problem Skin Inflammation (2443)

Event Type  Injury  

Event Description

The following information was reported: customer reported several cases of severe dermatitis which developed using hollister flextend barriers with tape border.Topical interventions including domeboro soaks 2-4 times daily, lidex gel, antifungal powders were required.Users were adolescent patients with recent surgically created ostomies.Skin compromise occurred within 2 weeks of using products with the dermatitis beginning on the outer tape border.One girl went to the er and was admitted because she had replaced 10 pouches in 48 hours resulting in denuded (raw) and weepy skin to which pouches would not adhere.No additional information regarding severity, medical intervention, specific products or patient details could be obtained from the reporter.

Manufacturer Narrative

Repeated applications of flextend (extended wear) barriers with tape borders over a short period of time can result in raw weepy skin.

• Brand Name: FLEXTEND BARRIERS WITH TAPE BORDER
• Type of Device: OSTOMY
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister dr; libertyville IL 60048
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 999
• Manufacturer Contact: anne riba ; 2000 hollister dr; libertyville, IL 60048 ; 8476805625
• MDR Report Key: 4974915
• MDR Text Key: 15895614
• Report Number: 1119193-2015-00009
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/06/2015,08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2015
• Initial Date Manufacturer Received: 07/06/2015
• Initial Date FDA Received: 08/05/2015
• 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: 999 YR
• Patient Weight: 453