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

Model Number 14603

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Unspecified Infection (1930)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

There was no evidence of device malfunction; customer reported that barrier functioned properly and did not leak.

Event Description

It was reported by the user that following the start of oral chemo in (b)(6) 2016 she has had two skin infections located under her barrier.The second infection occurred on (b)(6) 2016.Both infections were about the size of a dime and were treated with oral antibiotics.The user explained that the barrier did not cause the infection but when she removed the barrier it removed the skin/scab over the infection resulting in minimal bleeding.

• 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: 5755562
• MDR Text Key: 48343662
• Report Number: 1119193-2016-00015
• 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: 06/02/2016,06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• 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: 06/02/2016
• Date Manufacturer Received: 06/02/2016
• 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: 62 YR
• Patient Weight: 94