MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE FLEXTEND PRE SIZED BARRIER

Catalog Number 14703

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

Patient Problems Skin Infection (4544); Contact Dermatitis (4546)

Event Date 01/31/2021

Event Type  Injury  

Manufacturer Narrative

The end user's weight is not known so an estimate was used.The device history records were reviewed and found to be complete and accurate.The device not saved for return so device evaluation not possible.The trend analysis conducted showed no adverse trends for skin irritation.The root cause of the reported fungal infection and contact dermatitis is not known.

Event Description

It was reported that an end user who had been using hollister ostomy barriers since 2013, started developing skin irritation under the barrier and tape portion of the appliance in (b)(6) she has been seen by several health care professionals and prescribed nystatin powder, steroid pills and steroid cream and seeing some relief but the irritation is starting back up again under the tape border.She had been diagnosed with a fungal infection and then with dermatitis.Hollister will send out a different barrier product for her to sample.

• Brand Name: NEW IMAGE FLEXTEND PRE SIZED BARRIER
• Type of Device: NEW IMAGE FLEXTEND PRE SIZED BARRIER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. 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: 11877637
• MDR Text Key: 254794552
• Report Number: 1119193-2021-00015
• 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: 05/25/2021

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: 14703
• Device Lot Number: 1B052
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 05/25/2021
• 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: 48 YR
• Patient Weight: 54