MAUDE Adverse Event Report: HOLLISTER INCROPORATED PREMIER FLEXTEND POUCH WITH CTF BARRIER

Catalog Number 8631

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 07/14/2022

Event Type  Injury  

Manufacturer Narrative

Trend analysis conducted and no adverse trends for skin irritation identified.Device history record (dhr) review conducted and records found to be complete and accurate.Sample not returned so sample evaluation not possible.Root cause of skin irritation and bumps under the ostomy barrier cannot be determined.

Event Description

It was reported that an end user went to the doctor last thursday because she was experiencing skin irritation and red bumps under the hollister premier ostomy barrier.She reported that this affected her skin around her peristomal hernia under the barrier.She reported that the doctor said it was a "summer rash" and prescribed her two antibiotic creams that she was to mix together and used on her peristomal skin when she changed her barrier.The end user reported that she gets this rash in the summers and has previously used the creams.She said that this is not a lot-specific problem but rather has to do with her hernia and the weather.She reported that since starting the creams last thursday, the area has almost completely cleared up already.

• Brand Name: PREMIER FLEXTEND POUCH WITH CTF BARRIER
• Type of Device: PREMIER FLEXTEND POUCH WITH CTF BARRIER
• Manufacturer (Section D): HOLLISTER INCROPORATED; 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, IL 60048-3781 ; 8476802170
• MDR Report Key: 15104472
• MDR Text Key: 296594419
• Report Number: 1119193-2022-00027
• 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: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 8631
• Device Lot Number: 2C242
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2022
• 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: 60 YR
• Patient Sex: Female