MAUDE Adverse Event Report: HOLLISTER INCORPORATED APOGEE; INTERMITTENT CATHETER, 14 FR 16 IN, SOFT, STRAIGHT

Catalog Number	B1061
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Hematuria (2558)
Date of Event	03/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Trend analysis conducted and no adverse trends observed.Device history review could not be conducted because the lot number was not provided.Sample review not possible because sample was not provided for evaluation.Root cause of reported infection cannot be determined.Only the di information of the udi is known due to lack of lot number information.
Event or Problem Description
It was reported that a customer experienced bleeding after utilizing the hollister apogee straight intermittent urethral catheter.It was then reported during a follow-up call that the customer recently visited the er, where he was diagnosed with prostatitis and a testicular infection.Additionally, it was reported that he was placed on a foley catheter and prescribed a one-month course of antibiotics.

• Brand Name: APOGEE
• Common Device Name: INTERMITTENT CATHETER, 14 FR 16 IN, SOFT, STRAIGHT
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): HOLLISTER INCORPORATED; plot no. 27, sector-v; hsiidc growth centre; bawal, haryana 12350 1; IN 123501
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville, IL 60048-3781
• MDR Report Key: 24598950
• Report Number: 3008191244-2026-00003
• Device Sequence Number: 18238826
• Product Code: GBM
• UDI-Device Identifier: 00610075176724
• UDI-Public: (01)00610075176724
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K992137
• 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: B1061
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/13/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male