MAUDE Adverse Event Report: HOLLISTER, INC. APOGEE; INTERMITTENT CATHETER, 14 FR 16 IN, SOFT, STRAIGHT

Model Number	B1061
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	11/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient developed a uti.They were reported to be using the hollister apogee intermittent catheter.No medical attention was reported.It was also reported that the patient stated that "these did work" and that they had used them before.No further contact with the patient is possible, due to lack of contact information.No lot number provided.
Additional Manufacturer Narrative
Lot number not provided so dhr review not possible.Sample not returned so sample review not possible.End user denied a device malfunction.Only the di of the udi information is known due to lack of lot number information.A causation between the hollister apogee catheter and the reported uti could not be established.

• Brand Name: APOGEE
• Common Device Name: INTERMITTENT CATHETER, 14 FR 16 IN, SOFT, STRAIGHT
• 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: 23747396
• Report Number: 3008191244-2025-00002
• Device Sequence Number: 15832951
• Product Code: GBM
• UDI-Device Identifier: 00610075176724
• UDI-Public: 00610075176724
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K992137
• 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): 12/08/2025

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: B1061
• Device Catalogue Number: B1061
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2025
• Initial Report FDA Received Date: 12/08/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown