MAUDE Adverse Event Report: HOLLISTER INCORPORATED VAPRO; NO TOUCH URETHRAL INTERMITTENT CATHETER, HYDROPHILIC, STRAIGHT TIP, PROTECTIVE T

Model Number	72122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	08/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an end user found the eyelets on the catheter not large enough to pass debris from the bladder which caused the bladder to not empty and lead to a bladder infection.It was reported that the end user was diagnosed with a bladder infection by a general practitioner and was prescribed antibiotics.It was further reported that the end user was then instructed to catheterize more than once a day and to use a larger french catheter.
Additional Manufacturer Narrative
The device history records were reviewed based upon the lot number provided and the records were found to be complete and accurate.The sterilization documentation for this lot was also reviewed and no out of specification results were found.The root cause of the reported urinary tract infection cannot be determined.Causation has not been established.This product is not sold in the united states so there is no gudid information including di and pi information available.There is udi information availble and that is included in this report.This product is similar to the vapro 70124 sold in the united states.

• Brand Name: VAPRO
• Common Device Name: NO TOUCH URETHRAL INTERMITTENT CATHETER, HYDROPHILIC, STRAIGHT TIP, PROTECTIVE T
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. 60048 3781
• Manufacturer (Section G): HOLLISTER ULC; foxford rd.; rehins; ballina, ; EI
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville. 60048-3781 ; 8479321271
• MDR Report Key: 20182572
• Report Number: 9616668-2024-00003
• Device Sequence Number: 20898300
• Product Code: GBM
• UDI-Device Identifier: 00610075092598
• UDI-Public: (01)00610075092598(17)260101(30)30(10)4A223
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2024

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 Expiration Date: 01/01/2026
• Device Model Number: 72122
• Device Catalogue Number: 72122
• Device Lot Number: 4A223
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2024
• 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: Female