MAUDE Adverse Event Report: CURE MEDICAL LLC CURE MALE ULTRA; URINARY CATHETER

Model Number	ULTRAM16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	06/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During follow-up, the patient said he noticed no malfunction or defect with the catheters.After reviewing his catheterization technique, it was discovered that the patient doesn't always clean the insertion area routinely or wash his hands before catheterization when away from home.The patient was informed that cure medical's consultant nurse advises cleaning the insertion area routinely before insertion may reduce the chances for infection.
Event or Problem Description
Intermittent catheter patient (user) said he got a urinary tract infection (uti) back in june concurrent with catheter use.During follow-up, the patient said he was prescribed an antibiotic, took the full course of 14 days, and completely recovered.

• Brand Name: CURE MALE ULTRA
• Common Device Name: URINARY CATHETER
• Manufacturer (Section D): CURE MEDICAL LLC; 3471 via lido, #211; neport beach, ca 92663, us, ca
• MDR Report Key: 10434153
• Report Number: 3005471919-2020-00083
• Device Sequence Number: 3221785
• Product Code: KOD
• UDI-Device Identifier: 00815947021076
• UDI-Public: (01)00815947021076(17)221028(10)191114-1(241)ULTRAM16
• 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): 08/20/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/28/2022
• Device Model Number: ULTRAM16
• Device Catalogue Number: ULTRAM16
• Device Lot Number: 191114-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/20/2020
• 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: 79 YR
• Patient Weight: 109