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

Model Number	P14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During follow-up, the patient said there were no defects or malfunction with the p14 units.
Event or Problem Description
Intermittent catheter patient (user) said he got a urinary tract infection (uti) while using the p14 catheter.During follow-up, the patient said he was prescribed a 10 day course of antibiotic, took the full course, and recovered completely.

• Brand Name: CURE PEDIATRIC CATHETER
• Common Device Name: URINARY CATHETER
• Manufacturer (Section D): CURE MEDICAL LLC; 3471 via lido, #211; neport beach, ca 92663, us, ca
• MDR Report Key: 10292337
• Report Number: 3005471919-2020-00058
• Device Sequence Number: 859310
• Product Code: EZD
• UDI-Device Identifier: 00815947020284
• UDI-Public: (01)00815947020284(17)240728(10)190818-3(241)P14
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110653
• 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): 07/17/2020

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: 07/28/2024
• Device Model Number: P14
• Device Catalogue Number: P14
• Device Lot Number: 190818-3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 07/17/2020
• 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: 77 YR
• Patient Weight: 82