MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE FLEXTEND WITH TAPE BORDER, CUT TO FIT; OSTOMY BARRIER

Model Number 14603

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Inadequate Pain Relief (2388)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

The potential exists that this reported reaction to the barrier may be associated with a developed sensitivity to the product.Product has met the requirements of iso 10993 "biological evaluation of medical devices" and is not a known sensitizer.The dhr was reviewed and found to be accurate and complete.

Event Description

It was reported by the user that beginning in (b)(6) 2016, he experienced a skin rash at the lower outside edge of the barrier of his hollister new image 14603 ostomy barrier.He has been using the new image 14603 for 11 years without issues.The user went to his dermatologist who prescribed 0.1% triamcinolone acetonide cream to treat the rash.He is now on his 4th tube of cream and the rash has spread but is restricted to the outside edge of the barrier with no irritation underneath the barrier or around his stoma.He is trying a different barrier.

• Brand Name: NEW IMAGE FLEXTEND WITH TAPE BORDER, CUT TO FIT
• 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: 6523582
• MDR Text Key: 73759697
• Report Number: 1119193-2017-00013
• 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: 03/28/2017,04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• 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: 03/28/2017
• Date Manufacturer Received: 03/28/2017
• 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: 71 YR
• Patient Weight: 86