MAUDE Adverse Event Report: CURE MEDICAL LLC CURE MEDICAL CATHETER INSERTION KIT

Model Number	K1
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	11/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient (user) reported lubricant was too sticky and difficult to apply to the catheter which made insertion difficult.He feels the poor lubricant contributed to him acquiring a urinary tract infection.He was prescribed an antibiotic and recovered fully.

• Brand Name: CURE MEDICAL CATHETER INSERTION KIT
• Common Device Name: CATHETER INSERTION KIT
• Manufacturer (Section D): CURE MEDICAL LLC; 3471 via lido, #211; newport beach CA 92663
• MDR Report Key: 9678598
• Report Number: 3005471919-2020-00003
• Device Sequence Number: 11456627
• Product Code: OHR
• UDI-Device Identifier: 00815947020468
• UDI-Public: (01)00815947020468(17)200928(10)18301901(241)K1
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/28/2020
• Device Model Number: K1
• Device Catalogue Number: K1
• Device Lot Number: 18301901
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 02/06/2020
• 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: 73 YR
• Patient Weight: 79