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	01/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During follow-up, the patient said she has been using the twist brand product for 7 years and her recent order is the shortest at only 4.75" from the end of the funnel to the tip of the catheter.The patient was informed that the catheter length is still within specification, and that cure medical's consultant nurse says to slowly withdraw the catheter from one's body since more urine may drain.The patient said she moves it around but was not sure she withdraws it slowly and will try to withdraw slowly.
Event or Problem Description
Intermittent catheter patient (user) said she had a urinary tract infection (uti) concurrent with catheter use, and thinks it was caused by the catheter being too short and doesn't drain her bladder completely.During follow-up, the patient said she was prescribed an antibiotic, took the full course, but did not fully recover.She was prescribed a second dose, and fully recovered after the taking the second dose.

• 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: 11346050
• Report Number: 3005471919-2021-00026
• Device Sequence Number: 5036198
• Product Code: KOD
• UDI-Device Identifier: 00815947020390
• UDI-Public: (01)00815947020390(17)230328(10)200421-2(241)T14
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/18/2021

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: 03/28/2023
• Device Model Number: T14
• Device Catalogue Number: T14
• Device Lot Number: 200421-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/18/2021
• 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: 78 YR
• Patient Weight: 59