MAUDE Adverse Event Report: HOLLISTER INCROPORATED HOLLISTER PREMIER CONVEX TAPE BORDERED PRE-SIZED UROSTOMY APPLIANCE; HOLLISTER PREMIER CONVEX TAPE BORDERED PRE-SIZED UROSTOMY APPLIANCE

Catalog Number 8481

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

Patient Problems Itching Sensation (1943); Urticaria (2278)

Event Date 09/08/2021

Event Type  Injury  

Manufacturer Narrative

Trend analysis conducted and no adverse trends observed.Since lot number not provided a dhr review not possible.Sample not returned so sample evaluation not possible.Root cause of reported rash under the barrier cannot be determined.

Event Description

It was reported that an end user who was using the hollister premier ostomy appliance developed skin irritation, redness and itching under her barrier.The doctor prescribed nystatin pills and cream.That helped a little, but then the barrier would not adhere.She will be asking her doctor for nystatin powder.In addition, hollister will send her a different formulation of hollister's ostomy barriers without a tape border to see if that improves her skin.

• Brand Name: HOLLISTER PREMIER CONVEX TAPE BORDERED PRE-SIZED UROSTOMY APPLIANCE
• Type of Device: HOLLISTER PREMIER CONVEX TAPE BORDERED PRE-SIZED UROSTOMY APPLIANCE
• 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: 13002708
• MDR Text Key: 285085194
• Report Number: 1119193-2021-00039
• 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: Other
• Type of Report: Initial
• Report Date: 12/14/2021

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: 8481
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/14/2021
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 39 KG