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	04/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During follow-up, the patient said she hasn't changed her catheterization technique at all, and just tried the t14 about two months ago.She explained that she is very sensitive to many ingredients including parabens, one of the many ingredients in the lubricant of the t14.She concluded she must be sensitive to the lubricant on the t14, but didn't notice it since she has no sensation in that area.She noticed no defect or malfunction with the t14 catheter.
Event or Problem Description
Intermittent catheter patient (user) said she thinks she got a urinary tract infection (uti) from a catheter, as she hasn't had a uti since 2014.She now has had two uti's in the last month and is on medication.She thinks it could be something in the lubricant that may have caused the uti.During follow-up, the patient said she was prescribed an antibiotic and took the full course, but the infection was not resolved.She was prescribed another antibiotic and just finished the dose.She feels fine and will visit her doctor to confirm the infection was resolved.

• 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: 11986843
• Report Number: 3005471919-2021-00052
• Device Sequence Number: 19624551
• Product Code: KOD
• UDI-Device Identifier: 00815947020390
• UDI-Public: (01)00815947020390(17)221228(10)200115-2(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): 06/11/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/28/2022
• Device Model Number: T14
• Device Catalogue Number: T14
• Device Lot Number: 200115-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/11/2021
• 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: 67 YR