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

Model Number	F14
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Skin Irritation (2076); Urinary Tract Infection (2120); Burning Sensation (2146)
Date of Event	11/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient (user) reported that recently she was feeling some scratchiness and a slight burning sensation while using urinary catheters.During follow-up the patient reported she acquired a uti in november.Her doctor delayed prescribing an antibiotic and the uti spread to a bladder infection.The patient took antibiotic courses in december and january to treat the infection.After finishing the antibiotics the patient reported a complete recovery from the infection.

• Brand Name: CURE CATHETER
• Common Device Name: URINARY CATHETER
• Manufacturer (Section D): CURE MEDICAL LLC; 3471 via lido, #211; newport beach CA 92663
• MDR Report Key: 8291088
• Report Number: 3005471919-2019-00009
• Device Sequence Number: 11240829
• Product Code: EZD
• UDI-Device Identifier: 00815947020215
• UDI-Public: (01)00815947020215(17)230628(10)180711-4(241)F14
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K072539
• 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): 01/30/2019

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: 06/28/2023
• Device Model Number: F14
• Device Catalogue Number: F14
• Device Lot Number: 180711-4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2019
• Initial Report FDA Received Date: 01/30/2019
• 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: 48 YR
• Patient Weight: 52