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

Catalog Number 14903

Device Problem Biocompatibility (2886)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers.User has had her stoma since 2013 and has always used this product.Lot number not provided so dhr review is not possible.Sample not returned so a sample evaluation is not possible.Trend data reviewed and no adverse trend observed.

Event Description

It was reported that an end user started to observe irritation under her ostomy barrier in (b)(6) 2017.The irritation expanded to be under the tape portion of the barrier as time went on.The area was red, inflamed and weepy.She has been working on and off with a dermatologist for other skin issues since 2015.Treatment prescribed by her dermatologist for this irritation consisted of topical hydrocortisone cream, clobetasol cream and protopic cream with limited success.On april 13, 2018, the end user reached out to hollister about this issue and requested other ostomy appliances to sample in order to see if it helps improve the irritation.

• 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: 7494660
• MDR Text Key: 107604833
• Report Number: 1119193-2018-00017
• 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: Patient
• Type of Report: Initial
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 14903
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2018
• Initial Date FDA Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 62 YR
• Patient Weight: 79