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

Model Number	ULTRAM14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	11/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During follow-up, the patient said he did not notice any defects or malfunction with the ultram14 product and will keep using the product.He confirmed he now only catheterizes 3 days a week instead of every day.He discarded any units that he was using at the time the infection occurred, but provided a lot number he thought may be from the same lot.
Event or Problem Description
Intermittent catheter patient (user) said he gets recurring urinary tract infections (uti's) concurrent with catheter use, and has a back stock of catheters because he is not catheterizing at the moment.During follow-up, the patient said he was prescribed an antibiotic (amoxicillin), took the full course, but the infection was not resolved until he was given a different antibiotic (oxycycline).The patient has recovered.

• Brand Name: CURE MALE ULTRA
• Common Device Name: URINARY CATHETER
• Manufacturer (Section D): CURE MEDICAL LLC; 3471 via lido, #211; newport beach CA 92663
• MDR Report Key: 11097660
• Report Number: 3005471919-2020-00156
• Device Sequence Number: 16318700
• Product Code: KOD
• UDI-Device Identifier: 00815947021076
• UDI-Public: (01)00815947021076(17)250128(10)200113-3(241)ULTRAM14
• 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): 12/30/2020

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: 01/28/2025
• Device Model Number: ULTRAM14
• Device Catalogue Number: ULTRAM14
• Device Lot Number: 200113-3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/30/2020
• 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: 72 YR
• Patient Weight: 91