MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE FLEXWEAR TAPE BORDERED CUT TO FIT BARRIER

Catalog Number 14204

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

Patient Problems Skin Infection (4544); Skin Inflammation/ Irritation (4545)

Event Date 09/20/2022

Event Type  Injury  

Manufacturer Narrative

Trend analysis conducted for barrier allowing leakage and skin irritation for this sku and no adverse trends observed.Device history record (dhr) review conducted based upon the lot number provided and the records were found to be complete and accurate.Sample not returned so sample evaluation not possible.Root cause of reported skin irritation and infection from leakage of the ostomy barrier cannot be determined.

Event Description

It was reported that an ostomate using hollister new image barrier experienced barrier leakage.The end user reported that the leakage went into divots on her skin which contained healing surgical wounds.She said the leakage irritated the wounds and the wounds opened.The end user reported going to the doctor who said the wounds that opened were infected and that she will need surgery to remove the infection and close the wounds.Hollister is sampling some alternative types of barriers and other supplies for the end user to try.

• Brand Name: NEW IMAGE FLEXWEAR TAPE BORDERED CUT TO FIT BARRIER
• Type of Device: NEW IMAGE FLEXWEAR TAPE BORDERED CUT TO FIT 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: 15495615
• MDR Text Key: 300700995
• Report Number: 1119193-2022-00035
• 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: 09/27/2022

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: 14204
• Device Lot Number: 2A319
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 09/27/2022
• 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: 48 YR
• Patient Sex: Female