MAUDE Adverse Event Report: HOLLISTER INCORPORATED VAPRO PLUS POCKET; VAPRO PLUS PKT HYDROPHILIC IC CH12 40CM

Model Number	71124-2-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dysuria (2684)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No customer product sample is available for investigation.Lot number provided and a dhr review was conducted.All records were complete and accurate.Review of the sterilization batch record demonstrated that the minimum and maximum qualified sterilization dose was obtained to support compliant sterile product release.A review of complaints showed that no other complaints were received for this sku and lot of product.This exact product is not sold in the us, but a similar sku is sold in the us.The root cause of the reported event could not be determined.Causation could not be established between the hollister urethral catheter and the reported symptoms.
Event or Problem Description
It was reported that an end user, who has been using the vapro plus pocket hydrabalance intermittent urethral catheter for approximately four weeks, has had difficulty inserting the catheter and describes a burning sensation in the urethra, or rather, an inflammation of the urethra.It was further reported that the end user saw a urologist who prescribed an antibiotic, which did not improve the condition.It was reported that the end user feels it is getting worse and wants to compare this catheter with one from another manufacturer.

• Brand Name: VAPRO PLUS POCKET
• Common Device Name: VAPRO PLUS PKT HYDROPHILIC IC CH12 40CM
• 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: 21949288
• Report Number: 3016675012-2025-00002
• Device Sequence Number: 8548006
• Product Code: GBM
• UDI-Device Identifier: 00610075094462
• UDI-Public: (01)00610075094462(17)261201(30)30(10)4L229
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K183253
• 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): 05/02/2025

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
• Device Lot Number: 4L229
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male