MAUDE Adverse Event Report: HOLLISTER INCORPORATED INFYNA CHIC; HYDROPHILIC URETHRAL INTERMITTENT CATHETER, STRAIGHT TIP

Catalog Number	8112
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the end user found the hollister infyna chic intermittent urethral catheters to be uncomfortable.It was further reported that the end user experienced a little bleeding and currently has a uti.
Additional Manufacturer Narrative
Trend analysis conducted and no adverse trends observed.Device history review and sterilization records review could not be conducted due to lack of lot number.Sample not returned so sample evaluation not possible.The root cause of the reported uti could not be determined.Only the di of the udi information is known due to lack of lot number information.

• Brand Name: INFYNA CHIC
• Common Device Name: HYDROPHILIC URETHRAL INTERMITTENT CATHETER, STRAIGHT TIP
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): HOLLISTER LIETUVA, UAB; oro parko g. 2, sergei; karmlavos sen., kaunas 54462 ; LH 54462
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville, IL 60048-3781
• MDR Report Key: 24593901
• Report Number: 3016675012-2026-00003
• Device Sequence Number: 10391809
• Product Code: EZD
• UDI-Device Identifier: 00610075072668
• UDI-Public: (01)00610075072668
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2026

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: 8112
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2025
• 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: Female