MAUDE Adverse Event Report: HOLLISTER INCORPORATED PREMIER DRAINABLE POUCH WITH CONVEX SKIN BARRIER; OSTOMY POUCH

Model Number 8512

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354)

Patient Problems Unspecified Infection (1930); Rash (2033)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

The root cause of the barrier not adhering cannot be determined.However, since the end user has been using this hollister appliance for 10-15 years, it is possible that there may have been a change in the user's skin condition that made the barrier not adhere as well.After the user had the assistance of the home health nurse, the fit was improved, the leakage stopped, and she had no more rashes.

Event Description

It was reported that the user had 3 emergency room visits between (b)(6) 2017 due to a rash resulting from stoma effluent leakage.The user noted that the barrier was not adhering well and leakage occurred.The rash was located on her right lower quadrant and thigh.The rash was diagnosed as a yeast infection and was treated with antibiotics and antifungals.The user is now using stoma powder with her ostomy appliances and the rash has resolved.

• Brand Name: PREMIER DRAINABLE POUCH WITH CONVEX SKIN BARRIER
• Type of Device: OSTOMY POUCH
• Manufacturer (Section D): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• 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: 7042273
• MDR Text Key: 92458436
• Report Number: 1119193-2017-00037
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 09/29/2017,11/17/2017

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 8512
• Device Catalogue Number: 8512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 09/29/2017
• Initial Date Manufacturer Received: 09/29/2017
• Initial Date FDA Received: 11/17/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 67