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

Catalog Number 14603

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

Patient Problem Skin Irritation (2076)

Event Date 07/17/2018

Event Type  Injury  

Manufacturer Narrative

End user's weight not known so estimation used.Trend data reviewed and no adverse trend observed.Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers.Dhr review conducted and results found to be complete and accurate.Sample review not possible because no sample available.The root cause of the skin irritation cannot be determined.

Event Description

It was reported that an end user has been experiencing skin irritation of his peristomal skin over the past 2 years while using the hollister ostomy barrier.He has been to a dermatologist who diagnosed it as atopic dermatitis and was prescribed methotrexate and doxycycline.This condition resolves and then reappears.He will follow up with his ostomy nurse and hollister is sending other samples of ostomy barriers for him to try.

• Brand Name: NEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT BARRIER
• Type of Device: NEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT BARRIER
• 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., ; 6802170
• MDR Report Key: 10333347
• MDR Text Key: 200636035
• Report Number: 1119193-2020-00017
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/28/2020

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: 14603
• Device Lot Number: 9J122
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 07/28/2020
• 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: 43 YR
• Patient Weight: 82