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

Model Number	ULTRAM12
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	10/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During follow-up, the patient said his doctor suggested the patient should just wait longer to let the urine drain fully from his bladder, because the bladder needs to be completely emptied to avoid infection.The patient said it was inconvenient to wait a long time.He has tried removing the catheter slowly and letting it drain more or twisting a little.He thinks the lubricant on the catheter may be just too much and may block the eyelets, somewhat slowing the drainage.The patient was use to another catheter product brand and added lubricant for insertion.The patient said he thought all the ultram12 catheters had the same amount of lubricant, but perhaps too much for his needs.
Event or Problem Description
Intermittent catheter patient (user) said he's been getting urinary tract infections (uti) concurrent with catheter use, and his doctor believes it's due to his bladder not fully emptying.He said he has trouble emptying his bladder with these catheters because it seems to him the lubricant builds up and blocks it.During follow-up, the patient said he was prescribed antibiotics at an urgent care center, but the infection was not resolved and was admitted to the hospital for treatment.He was put on intravenous (iv) antibiotics to treat the infection, and the infection was resolved.

• 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: 10878628
• Report Number: 3005471919-2020-00140
• Device Sequence Number: 16851325
• Product Code: KOD
• UDI-Device Identifier: 00815947021076
• UDI-Public: (01)00815947021076(17)221128(10)191203-1(241)ULTRAM12
• 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): 11/20/2020

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: 11/28/2022
• Device Model Number: ULTRAM12
• Device Catalogue Number: ULTRAM12
• Device Lot Number: 191203-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 11/20/2020
• 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: Hospitalization; Other
• Patient Age: 60 YR
• Patient Weight: 107