MAUDE Adverse Event Report: HOLLISTER INCORPORATED VAPRO PLUS POCKET; NO TOUCH URETHRAL INTERMITTENT CATHETER WITH INTEGRATED COLLECTION BAG, HYDROPHI

Model Number	71124-2-30
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number is not known so only the di information from the udi is known.A dhr review is not possible because the lot number was not provided.The dhr review and trend analysis could not be performed due to lack of information.A causation between the hollister catheter usage and the end user's reported internal trauma could not be established.
Event or Problem Description
It was reported that an end user experienced internal trauma while using the hollister vapro plus pocket intermittent urinary catheter to catheterize her mitrofanoff continent urinary channel.It was further reported that the catheter was significantly stifferand less flexible, resulting in painful insertions and injuries that required emergency care.It was reported that the end user experienced multiple false passages, bleeding, internal trauma, and repeated visits and procedures at the (b)(6).It was reported that the end user needed to wear a foley bag for two months to allow time to heal.It was additionally reported that in the first or second week of june she had complete blockage and had to have a foley inserted to allow the false passages to heal.It was further reported that the end user is a long-term user of the original vapro plus pocket catheters and had no issues until the newer model was introduced.

• Brand Name: VAPRO PLUS POCKET
• Common Device Name: NO TOUCH URETHRAL INTERMITTENT CATHETER WITH INTEGRATED COLLECTION BAG, HYDROPHI
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): HOLLISTER LIETUVA UAB; oro parko str. 2, sergeicikai; karmelavos; kauno raj.,, ltu LT-54 462; LH LT-54462
• Manufacturer Contact: katelynn nitschneider ; 2000 hollister drive; libertyville, IL 60048-3781 ; 8479321835
• MDR Report Key: 22700373
• Report Number: 3016675012-2025-00007
• Device Sequence Number: 9150315
• Product Code: GBM
• UDI-Device Identifier: 00610075054008
• UDI-Public: (01)00610075054008
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K183253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/04/2025

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: 71124-2-30
• Device Catalogue Number: 71124-2-30
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 08/04/2025
• 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; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Female