MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE CONVEX FLEXTEND CTF WITH TAPE

Catalog Number 14803

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

Patient Problem Abrasion (1689)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

End user did not save device for evaluation.End user does not have internet so photos could not be provided to the manufacturer for review.Lot number not provided so dhr review could not be conducted.Trend data reviewed and this is the only complaint of bleeding from the stoma for this sku over the last 3 years.No medical professional stated that the blood from the stoma had anything to do with the hollister ostomy barrier.Root cause of this reported issue cannot be determined.Weight not provided so estimation used.

Event Description

It was reported that an end user has been using the hollister cut-to-fit ostomy barrier since 2014.For over the past 2 years, she would occasionally experienced small amounts of bleeding from her stoma, which increased about a year ago when she was put on a series of blood thinners.The bleeding would stop when she would dab the area with a tissue.She could not tell where the bleeding was coming from.Her doctor, while conducting her colonoscopy, used chemical cautery on areas of her stoma which may have been bleeding.The cautery was done again during her follow up appointment.No doctor has indicated that the bleeding was from her ostomy barrier.She denies any malfunction of the barrier.She cuts the barrier opening so it is smooth.

• Brand Name: NEW IMAGE CONVEX FLEXTEND CTF WITH TAPE
• Type of Device: NEW IMAGE CONVEX FLEXTEND CTF WITH TAPE
• 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: 10006259
• MDR Text Key: 192181559
• Report Number: 1119193-2020-00008
• 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: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 14803
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 64