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

Model Number	T14
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	05/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During follow-up, the patient said she did experience some scraping from a rough eyelet on a t14 catheter just previously to acquiring the uti which may have contributed to getting the uti.She discarded the unit, and never experienced any other scraping incidents with the rest of the units from the same box or from any other orders.
Event or Problem Description
Intermittent catheter patient (user) said she got a urinary tract infection (uti) while using the t14 catheter, although she didn't specify it was the catheter that caused the uti.During follow-up, the patient reported she took the full course of antibiotics and recovered fully.

• Brand Name: TWIST CATHETER
• Common Device Name: URINARY CATHETER
• Manufacturer (Section D): CURE MEDICAL LLC; 3471 via lido, #211; neport beach, ca 92663, us, ca
• MDR Report Key: 10201629
• Report Number: 3005471919-2020-00047
• Device Sequence Number: 2297727
• Product Code: KOD
• UDI-Device Identifier: 00815947020390
• UDI-Public: (01)00815947020390(17)220828(10)190924-1(241)T14
• Combination Product (Y/N): N
• 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): 06/26/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/28/2022
• Device Model Number: T14
• Device Catalogue Number: T14
• Device Lot Number: 190924-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 06/26/2020
• 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: 58 YR
• Patient Weight: 75