MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE CONVEX FLEXTEND BARRIER WITH TAPE BORDER; OSTOMY POUCHING SYSTEM

Model Number 14803

Device Problem Fluid/Blood Leak (1250)

Patient Problem Skin Irritation (2076)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

Although the user had been using the same product for approximately 5 years, it appears that his needs had changed and convexity was no longer needed.There was no evidence of a device malfunction.

Event Description

It was reported by the user that in (b)(6) of 2017 he switched from the hollister 14803 new image convex barrier to a convatec convex ostomy barrier.He had been using the hollister 14803 for about 5 years.With the new barrier he had leakage and needed frequent appliance changes resulting in irritated peristomal skin.The user went back to his hollister 14803 new image convex barrier.On approximately (b)(6), he observed a small peristomal wound approximately 0.6" from the stoma.He tried antifungal medicine which did not help.The wound enlarged to the size and depth of a pencil eraser.On (b)(6) 2017, he saw a wocn who felt the wound was from the convexity.She cleaned and dressed the wound with a silver dressing and switched him to a flat barrier.As of (b)(6) he is improving and the wound is healing.

• Brand Name: NEW IMAGE CONVEX FLEXTEND BARRIER WITH TAPE BORDER
• Type of Device: OSTOMY POUCHING SYSTEM
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville IL 60068
• 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: 7157470
• MDR Text Key: 96179248
• Report Number: 1119193-2018-00001
• 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: 12/08/2017,01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 14803
• Device Catalogue Number: 14803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Report to Manufacturer: 12/08/2017
• Date Manufacturer Received: 12/08/2017
• 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: 38 YR
• Patient Weight: 77