MAUDE Adverse Event Report: CURE MEDICAL LLC CURE CATHETER FEMALE; URINARY CATHETER

Model Number	F14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	08/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During follow-up, the patient reported she was prescribed antibiotics and recovered after taking the course of antibiotics for 8 days.She said her doctor believes that the infections were caused by her craterization process and advised her to change to a prelubricated product so she does not have to add the lubricant.
Event or Problem Description
Intermittent catheter patient (user) reported she was advised to change to prelubricated catheters and discontinue using catheters she has on hand.She reported she was adding lubricant to the catheters and her doctor believes she was getting urinary tract infections (uti) because of the process.

• Brand Name: CURE CATHETER FEMALE
• Common Device Name: URINARY CATHETER
• Manufacturer (Section D): CURE MEDICAL LLC; 3471 via lido, #211; neport beach, ca 92663, us CA 92663
• MDR Report Key: 9089422
• Report Number: 3005471919-2019-00067
• Device Sequence Number: 19407611
• Product Code: KOD
• UDI-Device Identifier: 00815947020215
• UDI-Public: (01)00815947020215(17)231128(10)181206-1(241)F14
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K072539
• 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): 09/20/2019

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: 11/28/2023
• Device Model Number: F14
• Device Catalogue Number: F14
• Device Lot Number: 181206-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/19/2019
• 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: 79 YR
• Patient Weight: 83