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

Catalog Number 85211

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 07/13/2022

Event Type  Injury  

Event Description

An end user reported skin redness and irritation under the hollister premier ostomy barrier starting 3 days after her ileostomy surgery.She reported effluent leakage and that barrier not adhering well.She stated that she believes it was due to her learning how to use the right ostomy appliance since she had a flat stoma and at first wasn't using convexity.In addition, she reported that last week her doctor said it is peristomal dermatitis and prescribed nystatin powder to prevent a yeast infection.She just started using the nystatin powder this morning.She further reports her skin is sensitive from dialysis and itches a lot.She will be trailing a different formulation of hollister barrier material to see if it works better for her.

Manufacturer Narrative

Trend analysis conducted and no adverse trends for barrier allowing leakage or skin irritation identified.Device history record (dhr) review could not be conducted because lot number was not provided.Sample not returned so sample evaluation not possible.Root cause of barrier allowing leakage under the ostomy barrier and skin irritation cannot be determined.

• Brand Name: PREMIER CONVEX LNR POUCH WITH CTF BARRIER
• Type of Device: PREMIER CONVEX LNR 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: 15104261
• MDR Text Key: 296592566
• Report Number: 1119193-2022-00026
• 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: 85211
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2022
• 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: 53 YR
• Patient Sex: Female