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

Model Number	T14
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	11/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During follow-up, the patient said she noticed no defects or malfunction with the t14 catheter, but was sensitive to the lubricant.She experienced irritation repeatedly and visited her doctor to be tested for uti's but found no infection.She uses the t14 catheter when she goes out, but a non-lubricated catheter when she is at home.After remaining at home for some time due to covid-19 rules, she discovered she had no irritation while using her other catheters.She uses no lubricant with them.Once she began using the t14 again when going out, she experienced the same irritation again, and acquired one uti while using the t14 catheter.The patient also provided another lot number,191220-1, but was unable to confirm the lot number of the unit that caused the uti and if it was from this lot.
Event or Problem Description
Intermittent catheter patient (user) said the pre-lubrication of the catheter is causing urinary tract infections (uti).During follow-up, the patient said she was prescribed an antibiotic, took the full course, but did not recover from the infection.She was given a second course of a different antibiotic, and recovered fully.

• 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: 11181734
• Report Number: 3005471919-2021-00007
• Device Sequence Number: 14170668
• Product Code: KOD
• UDI-Device Identifier: 00815947020390
• UDI-Public: (01)00815947020390(17)230128(10)200228-2(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
• 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): 01/15/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/28/2023
• Device Model Number: T14
• Device Catalogue Number: T14
• Device Lot Number: 200228-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 01/15/2021
• 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: 40 YR
• Patient Weight: 70