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

Model Number	T14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	11/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although the cause of the adverse event cannot be determined, cure medical agrees with the patient's assertion that reuse of the single-use device is a likely contributor.
Event or Problem Description
Patient (user) reported she contracted a urinary tract infection (uti).She was prescribed a 7 day course of keflex to treat the infection.No defect or malfunction was reported with the catheter.The patient said she is forced to reuse some catheters because her insurance does not cover the quantity required for her needs.She said she thinks the reuse is the contributing factor for her acquiring infections.She is working with her doctor to get documentation submitted to insurance with the hope of being approved for additional supplies.

• Brand Name: TWIST CATHETER
• Common Device Name: URINARY CATHETER
• Manufacturer (Section D): CURE MEDICAL LLC; 3471 via lido, #211; newport beach CA 92663
• MDR Report Key: 9453371
• Report Number: 3005471919-2019-00081
• Device Sequence Number: 19385647
• Product Code: KOD
• UDI-Device Identifier: 00815947020390
• UDI-Public: (01)00815947020390(17)210928(10)181025-1(241)T14
• 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
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2019

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: 09/28/2021
• Device Model Number: T14
• Device Catalogue Number: T14
• Device Lot Number: 181025-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/11/2019
• 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: 31 YR
• Patient Weight: 71