MAUDE Adverse Event Report: Hollister Incorporated Advance Plus; Closed System Intermittent Catheter Kit, 16 Fr 16 in, Coude CLOSE

Catalog Number	97164
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury

• Brand Name: Advance Plus
• Common Device Name: Closed System Intermittent Catheter Kit, 16 Fr 16 in, Coude CLOSE
• Manufacturer (Section D): Hollister Incorporated; 2000 hollister drive; libertyville IL 60048 -378
• Manufacturer (Section G): Hollister Incorporated; plot no.27, sector-v; hssiidc growth centre; haryana, 12350 1; IN 123501
• Manufacturer Contact: andrea clark ; 2000 hollister drive; libertyville, IL 60048 ; +1(463)266-7911
• MDR Report Key: 50155601
• Report Number: 3008191244-2026-00007
• Device Sequence Number: 10572026
• Product Code: KOD
• UDI-Device Identifier: 00610075971640
• UDI-Public: (01)00610075971640
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 08/06/2026

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: 97164
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male