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

Model Number	ULTRAM16C
Medical Device Problem Codes	Difficult to Insert (1316); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During follow-up, the patient said the gel product like the ultram16c catheter is not as easy to insert since it didn't have enough lubricant and not as large compared to his preferred product (another hydrophilic catheter brand).The difference between the lubricants of the two products is the ultram16c is coated with a water based gel lubricant while his preferred product is coated with a hydrophilic coating.
Event or Problem Description
Intermittent catheter patient (user) said there was not enough lubricant on ultram16c catheters and they also gave him a urinary tract infection (uti).During follow-up, the patient said he was prescribed an antibiotic, took the full course, but the infection was not resolved so he had to take another course of antibiotics that he was still taking.

• 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: 10439868
• Report Number: 3005471919-2020-00085
• Device Sequence Number: 14131672
• Product Code: KOD
• UDI-Device Identifier: 00815947021120
• UDI-Public: (01)00815947021120(17)230128(10)200210-4(241)ULTRAM16C
• 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): 08/21/2020

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: 01/28/2023
• Device Model Number: ULTRAM16C
• Device Catalogue Number: ULTRAM16C
• Device Lot Number: 200210-4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 08/21/2020
• 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 Weight: 84