MAUDE Adverse Event Report: HOLLISTER INCORPORATED VAPRO PLUS F-STYLE 14 FR 40 CM; HYDROPHILIC INTERMITTENT URINARY CATHETER

Catalog Number	7700144
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Sepsis (2067); Genital Bleeding (4507)
Date of Event	12/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
An end user reported that the vapro plus intermittent hydrophilic urinary catheter was difficult for him to insert and remove.He reported that when he removed it, a blood vessel was injured and he bled.He reported he waited a few days and saw a doctor because the bleeding wouldn't stop.He said he saw a urologist who arranged from him to be admitted to the hospital.The end user did not report if any medical treatment was needed for the bleeding to stop.The end user said he waited until the next day to go to the hospital.The end user further reported that the night before he went to the hospital, he developed a fever and sepsis.The end user did not report what was the source of the sepsis.While in the hospital, the end user reported that he had an indwelling catheter and was on antibiotics.The end user reported that this was about a month ago.He reports that he is feeling fine now.
Additional Manufacturer Narrative
Product sample received but testing not yet completed.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.Hollister will submit a follow up report once the sample evaluation is completed.
Additional Manufacturer Narrative
Product sample received and examined.Visual and functional testing was completed, and all returned samples were within specifications.The root cause of this complaint cannot be determined.

• Brand Name: VAPRO PLUS F-STYLE 14 FR 40 CM
• Common Device Name: HYDROPHILIC INTERMITTENT URINARY CATHETER
• 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, IL 60048-3781 ; 8476802170
• MDR Report Key: 16333779
• Report Number: 9616668-2023-00001
• Device Sequence Number: 20537379
• Product Code: GBM
• UDI-Device Identifier: 00610075080649
• UDI-Public: 00610075080649
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/27/2023

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 Catalogue Number: 7700144
• Device Lot Number: 2F263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2022
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 94 KG