MAUDE Adverse Event Report: HOLLISTER, INC. APOGEE; APOGEE CLS SYSTEM IC 14FR 16IN

Model Number	B14F
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number provided and no discrepancy was observed in the dhr review.The post-sterilization report was reviewed and all sterilization parameters were found to be within the specified acceptance criteria, and no abnormalities or deviations were identified.Evaluation of control/retention samples included product weight measurement.No evidence of a dry catheter condition was observed in the retain samples evaluated.As the complaint sample was not available, the investigation was conducted using available complaint details, production records and control samples.A causation between the hollister apogee catheter and the reported uti was unable to be established.
Event or Problem Description
It was reported that an end user who had been using the hollister apogee catheters noticed less lubricant present over the last 2 shipments.It was further reported that the patient was catheterized regardless and it caused irritation.Additionally, it was reported that they saw a doctor due to the irritation, were diagnosed with a uti and then prescribed antibiotics.

• Brand Name: APOGEE
• Common Device Name: APOGEE CLS SYSTEM IC 14FR 16IN
• Manufacturer (Section D): HOLLISTER, INC.; 2000 hollister drive; libertyville IL 60048
• Manufacturer (Section G): HOLLISTER MEDICAL INDIA PRIVATE LIMITED; plot no. 27, sector 5; phase ii, hsiidc growth center; bawal, haryana 12350 1; IN 123501
• Manufacturer Contact: karen deering ; 2000 hollister drive; libertyville, IL 60048
• MDR Report Key: 24040252
• Report Number: 3008191244-2026-00001
• Device Sequence Number: 9057810
• Product Code: GBM
• UDI-Device Identifier: 20610075177114
• UDI-Public: (01)20610075177114(17)280501(30)100(10)5E276
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: B14F
• Device Catalogue Number: B14F
• Device Lot Number: 5E276
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male