MAUDE Adverse Event Report: HOLLISTER INCORPORATED PREMIER ONE PIECE DRAINABLE POUCH SYSTEM WITH CERAPLUS BARRIER AND TAPE BORDER; OSTOMY POUCHING SYSTEM

Model Number 89511

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Fungal Infection (2419)

Event Date 06/05/2017

Event Type  Injury  

Manufacturer Narrative

User appears to have developed a fungal infection under the tape border of the barrier.

Event Description

It was reported by the user that the skin under the tape border of the barrier had become crusty, bubbly and was weeping.The user had been using the premier sku (b)(4) for approximately one year prior to the irritation being noted.On (b)(6) 2017, his doctor diagnosed a yeast infection and he was prescribed diflucan by mouth for 6 days.After three weeks, the user is seeing improvement.He is additionally patting the area dry and using a stoma powder.

• Brand Name: PREMIER ONE PIECE DRAINABLE POUCH SYSTEM WITH CERAPLUS BARRIER AND 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: 6777993
• MDR Text Key: 82177943
• Report Number: 1119193-2017-00030
• 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: 06/29/2017,08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 89511
• Device Lot Number: 6I112
• 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: 06/29/2017
• Date Manufacturer Received: 06/29/2017
• 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): Other
• Patient Age: 56 YR
• Patient Weight: 79