MAUDE Adverse Event Report: HOLLISTER INCROPORATED PREMIER CONVEX FLEXTEND TAPE BORDERED UROSTOMY POUCHING SYSTEM

Catalog Number 84794

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

Patient Problem Rash (2033)

Event Date 04/26/2021

Event Type  Injury  

Manufacturer Narrative

Trend analysis conducted and no adverse trends observed for rash under the barrier.Since lot number not provided dhr review not possible.No evidence that this a is lot-specific issue.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 started developing a rash under the barrier of his hollister ostomy barrier about one year ago.The end user reported that it is a minor inconvenience which they manage by use of nystatin powder prescribed by his doctor.He reported that he uses the nystatin powder on and off whenever he experiences the rash.Hollister customer service is sending him other products to trial.

• Brand Name: PREMIER CONVEX FLEXTEND TAPE BORDERED UROSTOMY POUCHING SYSTEM
• Type of Device: PREMIER CONVEX FLEXTEND TAPE BORDERED UROSTOMY 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: 14277761
• MDR Text Key: 294618240
• Report Number: 1119193-2022-00013
• 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: 05/03/2022

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: 84794
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/04/2022
• 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: 64 YR
• Patient Sex: Male