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

Model Number	72124
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hematuria (2558)
Date of Event	10/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the end user had been catheterizing for at least the last 18 months and had recently noticed a difference with the lubricant and sleeve of the vapro catheter.It was further reported that the end user experienced bleeding when withdrawing the catheters from his urethra.It was reported that he went to the ed and they used a clamp to create a clot.It was also reported that he was referred to a urologist who had the end user undergo a ct scan to investigate his report, and the ct scan showed the urine was clear and no signs of cancer.The urologist suggested the end user try a tieman tip or other types of catheters.
Additional Manufacturer Narrative
A dhr review was conducted based on the lot number provided and the records were found to be complete and accurate.Sample not available.Complaint data review was conducted, and no adverse trends observed.The reporter was not able to provide an explanation as to what characteristics of the catheter caused or contributed to the reported bleeding.The root cause of the reported bleeding cannot be determined.It is not clear of the causation between the catheter use and the reported bleeding.Udi information provided but not gudid information since this product is not sold in the us.A similar product, sku 74144, is sold in the us.

• 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, mayo F26 F 3X5; EI F26 F3X5
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville. 60048-3781 ; 8479321271
• MDR Report Key: 20758781
• Report Number: 9616668-2024-00007
• Device Sequence Number: 18240907
• Product Code: GBM
• UDI-Device Identifier: 00610075092635
• UDI-Public: (01)00610075092635(17)260501(30)30(10)4E093(93)HX
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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: 05/01/2026
• Device Model Number: 72124
• Device Catalogue Number: 72124
• Device Lot Number: 4E093
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2023
• 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: Male