MAUDE Adverse Event Report: HOLLISTER INCORPORATED ONLI; ONLI HYDROPHILIC IC CH14 40CM

Catalog Number	82144
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Hematuria (2558)
Date of Event	06/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer samples not available.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 uti cannot be determined.The causation between the hollister onli catheter and the this end user's reported uti could not be confirmed.
Event or Problem Description
It was reported that an end user who had been using hollister's onli hydrophilic intermittent urinary catheter experienced an antibiotic resistant uti.Customer also reported he had a picc line in for a month.

• Brand Name: ONLI
• Common Device Name: ONLI HYDROPHILIC IC CH14 40CM
• 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: 17728043
• Report Number: 9616668-2023-00004
• Device Sequence Number: 6440344
• Product Code: GBM
• UDI-Device Identifier: 00610075072439
• UDI-Public: 00610075072439
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K211436
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2023

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 Expiration Date: 10/01/2024
• Device Catalogue Number: 82144
• Device Lot Number: 2J103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• 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 Sex: Male