MAUDE Adverse Event Report: HOLLISTER INCORPORATED ONLI HYDROPHILIC CATHETER CH12 17CM

Catalog Number	82121
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Burning Sensation (2146)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
An end user reported that she experienced burning and pelvic pain while using the hollister onli hydrophilic urethral catheter.She went to see her healthcare professional; was told she had a uti and was prescribed antibiotics.She also reported there were no problems opening or inserting the catheters and that the catheter was well hydrated.
Additional Manufacturer Narrative
The device history records were reviewed based upon the lot numbers provided and the records were found to be complete and accurate.The sterilization documentation for these lots were also reviewed and no out of specification results were found.We cannot infer a causal association between the onli catheter and the reported uti.The root cause cannot be determined.

• Brand Name: ONLI HYDROPHILIC CATHETER CH12 17CM
• Common Device Name: ONLI HYDROPHILIC CATHETER CH12 17CM
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. 60048 3781
• Manufacturer (Section G): HOLLISTER ULC; foxford rd.; rehins; ballina, county mayo ; EI
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville. 60048-3781
• MDR Report Key: 16672902
• Report Number: 9616668-2023-00002
• Device Sequence Number: 12121213
• Product Code: GBM
• UDI-Device Identifier: 00610075061914
• UDI-Public: 00610075061914
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2023

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: 82121
• Device Lot Number: 2H193
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 54 KG