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

Model Number 14603

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Rash (2033); Reaction (2414)

Event Date 04/01/2016

Event Type  Injury  

Manufacturer Narrative

There was no evidence of device malfunction; customer reports an allergic reaction to barrier.Biocompatibility testing in accordance with iso 10993 has been successfully completed on the barrier material.

Event Description

It was reported by the user that she had an ileostomy in (b)(6) of 2015 and was given a new image flextend barrier to use.A couple months following her ileostomy the area of skin over her stoma became "rashy".The inflammation was persistent and by (b)(6) or (b)(6) of 2016 the area had gotten deeper and started weeping and had a small amount of blood.On (b)(6) 2016 she had a biopsy of the area and it was determined that she had an allergic reaction to the barrier material.

• 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: 5851543
• MDR Text Key: 51339982
• Report Number: 1119193-2016-00019
• 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: 07/13/2016,08/05/2016

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 Model Number: 14603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Report to Manufacturer: 07/13/2016
• Initial Date Manufacturer Received: 07/13/2016
• Initial Date FDA Received: 08/05/2016
• 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): Other
• Patient Age: 36 YR
• Patient Weight: 79