MAUDE Adverse Event Report: CURE MEDICAL LLC CURE CATHETER CLOSED SYSTEM; URINARY CATHETER

Model Number	CS14C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	08/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During follow-up, the patient said he noticed no defect or malfunction with the cs14c product.
Event or Problem Description
Intermittent catheter patient (user) stated he is currently being treated by his doctor for a urinary tract infection (uti) concurrent with catheter use.During follow-up, the patient said he has taken five different courses of different antibiotics and is still infected.He was then placed on a seven day course of shots which require him to go to the hospital each day to receive with hope that the treatment will cause him to recover from the infection.

• Brand Name: CURE CATHETER CLOSED SYSTEM
• Common Device Name: URINARY CATHETER
• Manufacturer (Section D): CURE MEDICAL LLC; 3471 via lido, #211; newport beach CA 92663
• MDR Report Key: 10803651
• Report Number: 3005471919-2020-00133
• Device Sequence Number: 3267060
• Product Code: KOD
• UDI-Device Identifier: 00815947020697
• UDI-Public: (01)00815947020697(17)220828(10)191226-1(241)CS14C
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K080881
• 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): 11/06/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/28/2022
• Device Model Number: CS14C
• Device Catalogue Number: CS14C
• Device Lot Number: 191226-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 11/06/2020
• 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: 61 YR
• Patient Weight: 91