MAUDE Adverse Event Report: HOLLISTER INCROPORATED PREMIER SOFT CONVEX CERA PLUS TAPE BORDERED POUCHING SYSTEM

Catalog Number 8961

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 08/05/2022

Event Type  Injury  

Manufacturer Narrative

Trend analysis conducted and no adverse trends for tape causing skin irritation identified.Device history record (dhr) review conducted and records found to be complete and accurate.Sample not returned so sample evaluation not possible.Root cause of the reported yeast infection under the ostomy tape border cannot be determined.

Event Description

It was reported that an end user experienced skin irritation under the tape border of her ostomy appliance.She reported that she went to her dermatologist last week who looked at the area without removing her appliance.She further reported that the dermatologist did a skin culture and the results showed there was a mild yeast infection.She reported that the doctor prescribed ketoconazole, an antifungal cream to be used for about a month on the affected skin and she states that the area is already looking better.

• Brand Name: PREMIER SOFT CONVEX CERA PLUS TAPE BORDERED POUCHING SYSTEM
• Type of Device: PREMIER SOFT CONVEX CERA PLUS TAPE BORDERED POUCHING SYSTEM
• 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: 15234485
• MDR Text Key: 297981178
• Report Number: 1119193-2022-00028
• 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: 08/16/2022

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 8961
• Device Lot Number: 1L142
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2022
• Initial Date FDA Received: 08/16/2022
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 48 KG