MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE SOFT CONVEX CERAPLUS TAPE BORDERED PRESIZED BARRIER

Model Number 11905

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

Patient Problems Erythema (1840); Skin Inflammation/ Irritation (4545)

Event Date 12/07/2022

Event Type  Injury  

Manufacturer Narrative

Trend analysis conducted for tape border causing skin irritation for this sku and no adverse trends observed.Device history record (dhr) review could not be conducted because lot number was not provided.Sample not returned so sample evaluation not possible.Root cause of reported skin irritation under the ostomy tape border cannot be determined.

Event Description

The end user reported that she is experiencing red, raw, weeping skin under the tape border of her hollister ostomy barrier.She reports having a history of sensitivity to medical tape.She stated her ostomy nurse looked at the skin and suggested she see her doctor.She said she saw her doctor about 3 weeks ago and he said it was probably a yeast infection and prescribed nystatin powder.She said the area is still weepy.Hollister is sending samples for her to try that do not have a tape border.

• Brand Name: NEW IMAGE SOFT CONVEX CERAPLUS TAPE BORDERED PRESIZED BARRIER
• Type of Device: NEW IMAGE SOFT CONVEX CERAPLUS TAPE BORDERED PRESIZED 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: 16085424
• MDR Text Key: 306500289
• Report Number: 1119193-2023-00001
• 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: 01/03/2023

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 Model Number: 11905
• Device Catalogue Number: 11905
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2022
• Initial Date FDA Received: 01/03/2023
• 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: 71 YR
• Patient Sex: Female