MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER; NEW IMAGE TWO PIECE OSTOMY SKIN BARRIER

Model Number 14603

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Erosion (2075)

Event Date 01/25/2018

Event Type  Injury  

Manufacturer Narrative

The patient's blisters being distal to the location of the new image skin barrier makes it difficult to confirm that the medical device may have caused or contributed to the patient's allergic response.No known patch testing was done by the health care practitioner on the patient's skin to identify or confirm sensitivity to one or more ingredients in the skin barrier material.The report of allergy to the barrier was based upon the health care professional's statement.

Event Description

It was reported that the user had her stoma surgery in (b)(6) 2017.On (b)(6) 2018, she developed blisters on her hands, feet and some on her arms as well.No blisters were noted in the peristomal area.She saw her doctor who felt she has an allergy to the hollister barrier.She was prescribed prednisone and switched to a coloplast ostomy barrier.She has a history of allergy to band-aids and white medical tape.She said she is seeing some improvement since the change of barrier and prednisone but still has blisters.

• Brand Name: NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER
• Type of Device: NEW IMAGE TWO PIECE OSTOMY SKIN BARRIER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: benjamin lichtenwalner ; 2000 hollister drive; libertyville, IL 60048-3781 ; 8479183497
• MDR Report Key: 7292909
• MDR Text Key: 100888583
• Report Number: 1119193-2018-00008
• 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: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 14603
• Device Catalogue Number: 14603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 65