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

Model Number 11904

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

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

Event Date 10/20/2022

Event Type  Injury  

Manufacturer Narrative

Trend analysis conducted for barrier use causing skin irritation for this sku and no adverse trends observed.Device history record (dhr) review conduccted 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 redness and irritation under the ostomy barrier cannot be determined.

Event Description

It was reported that an ostomate using hollister's new image barrier developed skin that was red and raw under the barrier.She reported that she called her doctor and asked for something to be prescribed.She stated that she did not see her doctor but was prescribed nystatin cream over the phone based on what she described to her doctor.The end user reported that since she started using the cream, the red and raw area under the barrier is already improving.

• 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: 15715002
• MDR Text Key: 302853046
• Report Number: 1119193-2022-00036
• 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: 11/01/2022

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 Model Number: 11904
• Device Catalogue Number: 11904
• Device Lot Number: 2E202
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/02/2022
• 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: 60 YR
• Patient Sex: Female