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

Model Number	ULTRA12
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Skin Irritation (2076); Urinary Tract Infection (2120)
Date of Event	02/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient (user) reported she is sensitive to the lubricant and has been wiping it off the catheters before using them.Coinciding with catheter use the patient acquired a urinary tract infection.She has been prescribed an antibiotic and feels better now but she is still taking it (a 10 day course).Patient is changing to a catheter that is not pre-lubricated and plans to apply her own lubricant.

• Brand Name: ULTRA CATHETER
• Common Device Name: URINARY CATHETER
• Manufacturer (Section D): CURE MEDICAL LLC; 3471 via lido, #211; newport beach, ca
• MDR Report Key: 9781582
• Report Number: 3005471919-2020-00009
• Device Sequence Number: 2788136
• Product Code: KOD
• UDI-Device Identifier: 00815947020437
• UDI-Public: (01)00815947020437(17)220228(10)190312-2(241)ULTRA12
• 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): 03/03/2020

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: 02/28/2022
• Device Model Number: ULTRA12
• Device Catalogue Number: ULTRA12
• Device Lot Number: 190312-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2020
• Initial Report FDA Received Date: 03/03/2020
• 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: 70 YR
• Patient Weight: 77