MAUDE Adverse Event Report: HOLLISTER INCROPORATED PREMIER FLEXTEND UROSTOMY POUCH WITH CUT TO FIT BARRIER

Catalog Number 8460

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

Patient Problems Itching Sensation (1943); Rash (2033); Skin Erosion (2075); Urticaria (2278); Blister (4537)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

Sku/part number not provided so representative sku assigned to this report.Since sku number not provided, trend analysis could not be conducted.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.The treatment and outcome of any treatment is not known.Account not able to provide any further information or event details so hollister is unable to conduct an investigation or determine a root cause.

Event Description

It was reported that a patient who was using hollister's premier urostomy pouching system was found to have a moderate reaction with red open weeping rash and formation of large open peristomal wound.Symptoms included skin rash, urticaria, pruritus and blisters.

• Brand Name: PREMIER FLEXTEND UROSTOMY POUCH WITH CUT TO FIT BARRIER
• Type of Device: PREMIER FLEXTEND UROSTOMY POUCH WITH CUT TO FIT 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: 12699122
• MDR Text Key: 278408891
• Report Number: 1119193-2021-00033
• 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: 8460
• 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