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

Model Number	M12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	07/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During follow-up, the patient reported on his technique which may have caused or contributed to the reported event.Regarding his technique, the patient reported he takes an alcohol wipe to clean the top of the lubricating jelly container before applying lubricant to the catheter.Then he uses this same wipe to clean his penis.After cleaning the insertion area, he uses the same wipe to pick up the sterile catheter and hold it throughout insertion.This may cause contamination of the catheter.The patient was urged to discuss this technique with his doctor.
Event or Problem Description
Patient (user) reported he suffered a urinary tract infection (uti) and was prescribed an antibiotic for 10 days.He finished the course of antibiotics, but the infection did not go away.He explained he had to go into the hospital on (b)(6) 2019 due to pain.He said he was told he had a kidney stone and uti so was put on a foley and prescribed an antibiotic.The original infection had not gone away.

• 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: 8908428
• Report Number: 3005471919-2019-00059
• Device Sequence Number: 14135870
• Product Code: EZD
• UDI-Device Identifier: 00815947020024
• UDI-Public: (01)00815947020024(17)20240228(10)190313-5(241)M12
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 08/19/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2024
• Device Model Number: M12
• Device Catalogue Number: M12
• Device Lot Number: 190313-5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 08/19/2019
• 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: Hospitalization; Other
• Patient Age: 74 YR
• Patient Weight: 77