MAUDE Adverse Event Report: HOLLISTER INCROPORATED NEW IMAGE SOFT CONVEX CERAPLUS CUT TO FIT BARRIER

Catalog Number 11704

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 04/17/2022

Event Type  Injury  

Event Description

It was reported that an end user started developing a rash and oozing under the hollister ostomy skin barrier after using these products for 5 months.She reported that the rash spread to most of her body.She stated her doctor prescribed triamcinolone ointment and keflex for 7 days.She said the rash had not fully resolved so she was placed on oral prednisone and will see a wocn.She has since switched to a different hollister ostomy barrier and she reported it does not seem to cause this reaction.

Manufacturer Narrative

Trend analysis conducted and no adverse trends observed.Device history records reviewed for the lot number provided and found to be complete and accurate.Sample not returned so sample evaluation not possible.Root cause of reported reaction to the ostomy barrier cannot be determined.

• Brand Name: NEW IMAGE SOFT CONVEX CERAPLUS CUT TO FIT BARRIER
• Type of Device: NEW IMAGE SOFT CONVEX CERAPLUS 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: 14428816
• MDR Text Key: 291945838
• Report Number: 1119193-2022-00017
• 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: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 11704
• Device Lot Number: 2B192
• Was Device Available for Evaluation?: No
• Date Manufacturer 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: 63 YR
• Patient Sex: Female
• Patient Weight: 82 KG