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

Catalog Number 14603

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

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 01/10/2021

Event Type  Injury  

Manufacturer Narrative

The lot number is not known so the device history record review is not possible.The device not saved for return so device evaluation not possible.The trend analysis conducted showed no adverse trends.Estimates used for patient's weight because actual weight not provided.The root cause of the reported skin issue cannot be determined.

Event Description

It was reported that an end user experienced a leak under the barrier of his hollister new image barrier in mid-november.He then developed an allergic reaction to the tape adhesive and a yeast infection under the barrier along with itching.He tried over the counter medicine but it did not work.In the first part of january he had a virtual visit with his nurse who prescribed nystatin and then triamcinolone acetonide.End user would also take benadryl for the itch.The area was clearing up by not using the barrier but when he started using the barrier again, the rash returned.Hollister will send out a different barrier product for him to sample.

• Brand Name: NEW IMAGE FLEXTEND CUT TO FIT BARRIER
• Type of Device: NEW IMAGE FLEXTEND CUT TO FIT 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: 11302015
• MDR Text Key: 230988618
• Report Number: 1119193-2021-00008
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2021

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: 14603
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/09/2021
• 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: 66 YR
• Patient Weight: 68