MAUDE Adverse Event Report: HOLLISTER INCROPORATED PREMIER CONVEX UROSTOMY POUCH WITH PRE-SIZED BARRIER

Catalog Number 8483

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

Patient Problems Itching Sensation (1943); Rash (2033); Urticaria (2278)

Event Date 08/20/2021

Event Type  Injury  

Manufacturer Narrative

Trend analysis conducted and no adverse trends observed.Since lot number not provided dhr review not possible.Sample not returned so sample evaluation not possible.Patient's age, gender, weight and race not known.Root cause of reported peristomal skin rash cannot be determined.

Event Description

It was reported that a patient was using hollister pre-cut urostomy pouch and experienced a peristomal rash.He was treated with dakin solution for cleaning, then triamcinolone spray, and lastly thin hydrocolloid to block the reaction from the hollister barrier.This seems to have worked.The patient has been switched to a different brand of urostomy pouches with some success.Symptoms included rash, urticaria, and pruritus.

• Brand Name: PREMIER CONVEX UROSTOMY POUCH WITH PRE-SIZED BARRIER
• Type of Device: PREMIER CONVEX UROSTOMY POUCH WITH PRE-SIZED 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: 12699118
• MDR Text Key: 278411893
• Report Number: 1119193-2021-00035
• 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: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/26/2021

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: 8483
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 10/26/2021
• 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: 58 YR
• Patient Weight: 68