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

Model Number	72144-2-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	06/01/2024
Type of Reportable Event	Serious Injury
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 exact sku (72144-2-30) is not marketed in the us but a similar sku (70144) is.This mdr is based off of the similar sku.Udi information including di and pi information is available for 72144-2-30.
Event or Problem Description
It was reported that an end user who catheterizes 6 times a day for over 8 years and who uses the hollister vapro intermittent urethral catheters experienced a bladder infection in the beginning of (b)(6) 2024.The end user reported that he experiences utis at least once a year and that he always gets utis when his immune system breaks down or under stress.The end user reported that the health care professional also diagnosed him with prostatitis and prescribed him antibiotics.The end user further reported that crystals and sediment, which develop during the utis, blocked the catheter drainage eyelets and he needed to use a new catheter to drain his bladder.The end user did not report any damage to or breach in the catheter packaging.
Additional Manufacturer Narrative
Udi information corrected.Gudid information remains unavailable as this sku is not marketed in the united states.
Event or Problem Description
Follow-up 1 to correct udi information.

• 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: 20074627
• Report Number: 9616668-2024-00002
• Device Sequence Number: 17748305
• Product Code: GBM
• UDI-Device Identifier: 00610075092642
• UDI-Public: (01)00610075092642(17)260301(30)30(10)4C093(93)LE
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 08/28/2024

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: 03/01/2026
• Device Model Number: 72144-2-30
• Device Catalogue Number: 72144-2-30
• Device Lot Number: 4C093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2024
• 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 Age: 74 YR
• Patient Sex: Male