MAUDE Adverse Event Report: HOLLISTER INCOPORATED VAPRO; READY TO USE HYDROPHILIC INTERMITTENT CATHETER, 14 FR 16 IN, COUDE

Model Number	73144
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number is not known so only the di information from the udi is known.A dhr review is not possible because the lot number was not provided.A causation between the hollister catheter usage and the end user's reported uti could not be established.
Event or Problem Description
It was reported that the patient was diagnosed with a urinary tract infection (uti) and has been prescribed appropriate medication for treatment.

• Brand Name: VAPRO
• Common Device Name: READY TO USE HYDROPHILIC INTERMITTENT CATHETER, 14 FR 16 IN, COUDE
• Manufacturer (Section D): HOLLISTER INCOPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): HOLLISTER ULC; foxford road; rehins; ballina, county mayo F26 F 3X5; EI F26 F3X5
• Manufacturer Contact: katelynn nitschneider ; 2000 hollister drive; libertyville, IL 60048-3781 ; 8479321835
• MDR Report Key: 23016566
• Report Number: 9616668-2025-00021
• Device Sequence Number: 9747187
• Product Code: GBM
• UDI-Device Identifier: 00610075161690
• UDI-Public: (01)00610075161690
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2025

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: 73144
• Device Catalogue Number: 73144
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 09/10/2025
• 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: Required Intervention
• Patient Sex: Male