MAUDE Adverse Event Report: HOLLISTER INCORPORATED PREMIER CERAPLUS CUT TO FIT BARRIER WITH DRAINABLE POUCH

Catalog Number 8901

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

Patient Problem Skin Infection (4544)

Event Date 08/25/2020

Event Type  Injury  

Manufacturer Narrative

The device history records were reviewed and no issues identified.Root cause of the reported skin infection cannot be determined.(b)(4).

Event Description

It was reported that an end user experienced skin irritation, redness and itching under the tape portion of the hollister ostomy barrier.He went to the er on (b)(6) 2020 for this and was diagnosed with impetigo and prescribed mupirocin ointment to apply to the affected area.The area cleared up but it started up again when he used the tape over that area again.He reports having sensitive skin.Irritation has occurred before when using another ostomy appliance brand.Hollister will send him product to sample that does not have a tape border.

• Brand Name: PREMIER CERAPLUS CUT TO FIT BARRIER WITH DRAINABLE POUCH
• Type of Device: PREMIER CERAPLUS CUT TO FIT BARRIER WITH DRAINABLE POUCH
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville. 60048-3781 ; 8476802170
• MDR Report Key: 10535544
• MDR Text Key: 207127197
• Report Number: 1119193-2020-00024
• 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: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 8901
• Device Lot Number: 0F152
• Date Manufacturer Received: 09/10/2020
• 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: 77 YR
• Patient Weight: 67