MAUDE Adverse Event Report: HOLLISTER INCORPORATED VAPRO POCKET; SINGLE-ADMINISTRATION URETHRAL DRAINAGE CATHETER

Model Number	UNKNOWN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through a market research survey in the uk that an end user who had been using the hollister vapro pocket catheter reported that within two to three weeks they developed an infection.They further report that they been "battling them for almost a year".They reported that they are unsure of the cause of the infection but noted that the "only thing that's changed in my life was switching to the new catheters".No further information is available.
Additional Manufacturer Narrative
The lot number is not known, so complete udi information is unknown.The dhr review and trend analysis could not be performed due to unknown lot number.No additional information could be obtained as the end user chose not to be contacted.A causation between the hollister catheter usage and the end user's possible uti could not be established.The exact type of reported complication the end user experienced with the hollister catheter was not provided.Confirmation of a diagnosed uti was not able to be obtained by hollister.

• Brand Name: VAPRO POCKET
• Common Device Name: SINGLE-ADMINISTRATION URETHRAL DRAINAGE CATHETER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville 60048 3781
• Manufacturer (Section G): HOLLISTER ULC; foxford road; rehins; ballina, county mayo F26 F 3X5; EI F26 F3X5
• Manufacturer Contact: karen deering ; 2000 hollister drive; libertyville, IL 60048-3781
• MDR Report Key: 24162181
• Report Number: 9616668-2026-00001
• Device Sequence Number: 9268654
• Product Code: GBM
• UDI-Device Identifier: 15390166167139
• UDI-Public: 15390166167139
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2026

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: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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