MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE TRANSPARENT SKIN BARRIER WITH ADHESIVE BORDER; OSTOMY BARRIER

Model Number 14603

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Peeling (1999)

Event Date 03/29/2016

Event Type  Injury  

Manufacturer Narrative

Biocompatibility testing has been performed in accordance with is0 (b)(4) and materials were found to be non-sensitizers.

Event Description

It was reported by the user that for the last 1.5 years she has developed chronic ulcers under her barrier, pouch and paste.During this same time she has also developed reactions to the elastic band in her underwear, ekg electrodes, paper tape, bandaids and other manufacturer's ostomy products.She develops reactions under the skin where the pouch touches her.She has tried placing materials between the pouch and her skin but she develops reactions to those as well.She has had 90 skin patch tests including hollister products and they come up with a positive reaction.Her skin peels off when she develops these reactions and she often develops infections requiring antibiotics and steroid creams.

• Brand Name: NEW IMAGE TRANSPARENT SKIN BARRIER WITH ADHESIVE BORDER
• Type of Device: OSTOMY BARRIER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister dr; libertyville IL 60048
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: anne riba ; 2000 hollister dr; libertyville, IL 60048 ; 8476805625
• MDR Report Key: 5608876
• MDR Text Key: 43667099
• Report Number: 1119193-2016-00005
• 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: Patient
• Type of Report: Initial
• Report Date: 03/29/2016,04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 14603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Report to Manufacturer: 03/29/2016
• Date Manufacturer Received: 03/29/2016
• 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: 68 YR
• Patient Weight: 65