MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE FLEXTEND BARRIER, CUT TO FIT

Model Number 15604

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

Patient Problem Skin Irritation (2076)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers.Lot number not provided so dhr review is not possible.Sample not returned so a sample evaluation is not possible.Trend data reviewed and no adverse trend observed.End user's weight not provided so estimation used.The root cause of the skin irritation cannot be determined.

Event Description

It was reported that an end user has been experiencing skin irritation under the hollister ostomy barrier for 1 year.The irritated area is red, raw, bumps, burning, peeling and bleeding.The irritation is extending out beyond the borders of the ostomy barrier.She has been to the dermatologist and wocn numerous times and tried many medications and products without improvement.She is currently on miconazole powder and triamcinolone topical spray which may be helping.Hollister is providing ceraplus samples to try.

• Brand Name: NEW IMAGE FLEXTEND BARRIER, CUT TO FIT
• Type of Device: NEW IMAGE FLEXTEND BARRIER, CUT TO FIT
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville, il
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft, va
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville, il ; 3602170
• MDR Report Key: 10272023
• MDR Text Key: 198758215
• Report Number: 1119193-2020-00014
• 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: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 15604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 84