MAUDE Adverse Event Report: HOLLISTER INCORPORATED VAPRO PLUS POCKET; VAPRO PLUS PKT HYDROPHILIC IC CH14 40CM

Model Number	71144
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No customer product sample available for investigation.Lot number provided so a dhr review was conducted.Records were found to be complete and accurate.No other reports received for this type of complaint over the last 3 years.The root cause of the reported event could not be determined.Causation could not be established between the hollister urethral catheter and the reported black urine.
Event or Problem Description
It was reported that an end user experienced several episodes where his catheterized urine would look dark grey, almost black in color as seen in the collection bag of the hollister vapro plus pocket intermittent hydrophilic catheter product.It was reported that this would happen during a catheterization and then the next catheterization, the urine would go back to normal again (light yellow without cloudiness).It was reported that the end user went to urgent care and was told it was not a hollister issue but rather a medical matter of on again off again internal bleeding, despite not experiencing any pain, discomfort or any other physical symptoms.It was further reported that the end user was prescribed antibiotics.It was reported that the end user will make an appointment to see his doctor.

• Brand Name: VAPRO PLUS POCKET
• Common Device Name: VAPRO PLUS PKT HYDROPHILIC IC CH14 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: 20235499
• Report Number: 3016675012-2024-00003
• Device Sequence Number: 18176321
• Product Code: GBM
• UDI-Device Identifier: 00610075054015
• UDI-Public: (01)00610075054015(17)250801(30)30(10)3G239(93)HX
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K233524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2024

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: 08/01/2025
• Device Model Number: 71144
• Device Catalogue Number: 71144
• Device Lot Number: 3G239
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/17/2024
• 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
• Patient Sex: Male