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

Model Number	11416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	02/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a wheelchair bound paraplegic end user who uses the hollister apogee intermittent urinary catheters had ongoing pain and discomfort in his bladder.It was reported that this pain had been ongoing for 6 months.It was further reported that the end user believes the catheter packages did not have airtight seals.It was reported that the end user's urologist prescribed the use of foley catheters instead.It was further reported that the end user switched back to the hollister apogee catheters in february and several weeks later, his testicle had swollen to the size of a tennis ball.It was reported that he went to the emergency room and was diagnosed with epididymitis with hydrocele.It was further reported that the end user was admitted to the hospital for 5 days and was prescribed two weeks of bedrest, ice & antibiotics at discharge.
Additional Manufacturer Narrative
Representative samples from the same lot retained by the plant and returned from the patient were tested in the plant and passed the package integrity testing.No air leaks detected.The dhr review was completed and no issues identified.Sterilization records reviewed and no issues were identified.A causation between the apogee intermittent catheter and the reported epididymitis & cystocele could not be established.

• Brand Name: APOGEE IC
• Common Device Name: INTERMITTENT CATHETER, 14 FR 16 IN, STRAIGHT
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. IL 60048
• 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 ; 8479321271
• MDR Report Key: 19105322
• Report Number: 3008191244-2024-00001
• Device Sequence Number: 12689085
• Product Code: GBM
• UDI-Device Identifier: 00610075205240
• UDI-Public: 00610075205240
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2024

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 Model Number: 11416
• Device Catalogue Number: 11416
• Device Lot Number: 2L036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male