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U.S. Department of Health and Human Services

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

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HOLLISTER INCORPORATED FLEXTEND BARRIERS WITH TAPE BORDER; OSTOMY Back to Search Results
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.
 
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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 Key4974915
MDR Text Key15895614
Report Number1119193-2015-00009
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Manufacturer07/06/2015
Initial Date Manufacturer Received 07/06/2015
Initial Date FDA Received08/05/2015
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 Number1
Patient Outcome(s) Required Intervention;
Patient Age999 YR
Patient Weight453
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