MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE CONVEX TAPE BORDERED PRE SIZED BARRIER

Catalog Number 14905

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 05/09/2022

Event Type  Injury  

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 under the tape border of barrier cannot be determined.

Event Description

It was reported that an end user started developing irritation under the tape border of his hollister ostomy barrier 3 weeks ago.The end user reported that the doctor prescribed triamcinolone and he uses gauze to cover it.He reported that the doctor also prescribed a powder but it furthered the irritation.Hollister is sending the end user samples of skin barriers with the tape border.

• Brand Name: NEW IMAGE CONVEX TAPE BORDERED PRE SIZED BARRIER
• Type of Device: NEW IMAGE CONVEX TAPE BORDERED PRE SIZED 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: 14347926
• MDR Text Key: 291314124
• Report Number: 1119193-2022-00014
• 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: 05/10/2022

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: 14905
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 05/10/2022
• 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: 80 YR
• Patient Sex: Male