MAUDE Adverse Event Report: HOLLISTER INCROPORATED PREMIER CERAPLUS DRAINABLE POUCH WITH CTF BARRIER

Catalog Number 8931

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 07/11/2022

Event Type  Injury  

Manufacturer Narrative

Trend analysis conducted and no adverse trends for barrier allowing leakage identified.Device history record (dhr) review could not be conducted because lot number was not provided.Sample not returned so sample evaluation not possible.Root cause of barrier allowing leakage under the ostomy barrier cannot be determined.

Event Description

An end user reported that a week after getting her stoma, the hollister ostomy barrier that she was using allowed effluent leaking under the appliance and she had to change her appliance often.She reported that the leakage irritated her skin and removing the barrier irritated it further.She reported that she went to her primary care physician on monday and he said that the skin irritation was a fungal infection.She reported that the doctor prescribed nystatin powder.She stated her stoma does not protrude much above her skin level and the effluent can easily get under the barrier.She reported that the barrier has now stayed on for one full day.Hollister customer service is sending her soft convexity to try to see if that helps direct the effluent into the pouch better.

• Brand Name: PREMIER CERAPLUS DRAINABLE POUCH WITH CTF BARRIER
• Type of Device: PREMIER CERAPLUS DRAINABLE POUCH WITH CTF BARRIER
• Manufacturer (Section D): HOLLISTER INCROPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville, IL 60048-3781 ; 8476802170
• MDR Report Key: 15057033
• MDR Text Key: 296178520
• Report Number: 1119193-2022-00025
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 8931
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female