MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE FORMAFLEX TAPE BORDERED STRETCH TO FIT BARRIER

Catalog Number 14104

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 06/01/2022

Event Type  Injury  

Event Description

It was reported that an ostomate using hollister new image barrier developed skin irritation around the stoma a month ago.End user reported that there was effluent leakage around the stoma and the skin became irritated and weepy.She reported using 1% silver sulfadiazine ointment for this irritation around the stoma but it is no longer helping.Hollister is sampling some alternative barriers for her to try.

Manufacturer Narrative

Trend analysis conducted and no adverse trends observed.Lot number not provided so device history records could not be reviewed.Sample not returned so sample evaluation not possible.Root cause of reported skin irritation next to the stoma under the ostomy barrier cannot be determined.

• Brand Name: NEW IMAGE FORMAFLEX TAPE BORDERED STRETCH TO FIT BARRIER
• Type of Device: NEW IMAGE FORMAFLEX TAPE BORDERED STRETCH 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: 14988688
• MDR Text Key: 295714980
• Report Number: 1119193-2022-00023
• 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: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 14104
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2022
• 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: 45 YR
• Patient Sex: Female