MAUDE Adverse Event Report: HOLLISTER INCORPORATED VAPRO PLUS PKT HYDROPHILIC IC CH14 40CM; VAPRO PLUS POCKET

Catalog Number	71144
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	12/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No customer product sample available for investigation.No lot number provided on which to conduct a dhr review.No adverse complaint trends for this type of complaint observed.The root cause of the reported event cannot be determined.Causation could not be established between the hollister urethral catheter and the reported urinary tract infection.
Event or Problem Description
It was reported that after the hollister vapro plus pocket hydrophilic intermittent catheter was inserted and removed from the urethra, there was self-limiting blood upon removal of the catheter.It was further reported that two days later an infection developed with lower abdominal pain and purulent discharge.It was reported that the end user did not seek medical attention for this event and this observation was self-reported by the end user.It was reported that he used antibiotics for this event that was prescribed for him previously for treatment of a future uti.

• Brand Name: VAPRO PLUS PKT HYDROPHILIC IC CH14 40CM
• Common Device Name: VAPRO PLUS POCKET
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. IL 60048
• Manufacturer (Section G): HOLLISTER LIETUVA UAB; oro parko str. 2, sergeicikai; karmelavos; kauno raj., ltu LT-54 462; LH LT-54462
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville., IL 60046 ; 8479321271
• MDR Report Key: 18562049
• Report Number: 3016675012-2024-00001
• Device Sequence Number: 8043475
• Product Code: GBM
• UDI-Device Identifier: 00610075065332
• UDI-Public: 00610075065332
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K193148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 71144
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 01/23/2024
• 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