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

Catalog Number 84798

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

Patient Problems Skin Erosion (2075); Tissue Breakdown (2681)

Event Date 06/01/2021

Event Type  Injury  

Manufacturer Narrative

Trend analysis conducted and no adverse trends observed for skin irritation or pressure injury.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 peristomal wounds cannot be determined.

Event Description

It was reported that on (b)(6) 2021 an end user with a urostomy started experiencing peristomal wounds under the hollister premier convex barrier at about the same time he started using the new hope hernia belt with his hollister appliance.The end user reported that he needed to use a convex barrier and the hernia belt in order to prevent urine leakage due to multiple abdominal hernias.The end user reported that he is now seeing a wocn regularly who is using a cautery stick to cauterize areas of the wound that are bleeding and is using silver alginate wound dressings on the peristomal wounds.The end user reported that he does not believe the hollister appliance is malfunctioning or that this is related to any particular lot of appliance.Hollister is sending other ostomy products for him 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: 14085935
• MDR Text Key: 289089848
• Report Number: 1119193-2022-00009
• 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: 04/12/2022

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: 84798
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/07/2022
• Initial Date FDA Received: 04/12/2022
• 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
• Treatment: NEW HOPE 8" HERNIA BELT
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male