MAUDE Adverse Event Report: CURE MEDICAL LLC CURE CATHETER HYDROPHILIC COATED; URINARY CATHETER

Model Number	HP12
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	11/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During follow-up, the patient said she noticed sometimes the catheter package has a white substance in it near the tip after bursting the water packet, but noticed no other problems, defects, or malfunctions with the units.She discards any packages in which she sees a white substance.
Event or Problem Description
Intermittent catheter patient (user) reported finding a white substance prior to catheter use and had a urinary tract infection (uti).During follow-up, the patient said she was prescribed a one-day dose antibiotic twice, but they were not effective.She was given a course of bactrim, and is unsure if the infection was fully resolved.She will return to her doctor to have her urine tested to ensure she is completely recovered.

• Brand Name: CURE CATHETER HYDROPHILIC COATED
• Common Device Name: URINARY CATHETER
• Manufacturer (Section D): CURE MEDICAL LLC; 3471 via lido, #211; newport beach CA 92663
• MDR Report Key: 11174858
• Report Number: 3005471919-2021-00006
• Device Sequence Number: 14170667
• Product Code: EZD
• UDI-Device Identifier: 00815947021007
• UDI-Public: (01)00815947021007(17)230828(10)200922-1(241)HP12
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132500
• 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): 01/14/2021

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 Expiration Date: 08/28/2023
• Device Model Number: HP12
• Device Catalogue Number: HP12
• Device Lot Number: 200922-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR
• Patient Weight: 44