MAUDE Adverse Event Report: CURE MEDICAL LLC HYDROPHILIC COATED CURE CATHETER WITH INSERTION KIT; CATHETER CARE TRAY

Model Number	HM14UK
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	10/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Intermittent catheter patient (user) reported he experienced a urinary tract infection (uti) and the catheter felt different after using the catheter packaged with the catheter insertion kit (gloves, bzk wipe, collection bag, underpad).

• Brand Name: HYDROPHILIC COATED CURE CATHETER WITH INSERTION KIT
• Common Device Name: CATHETER CARE TRAY
• Manufacturer (Section D): CURE MEDICAL LLC; 3471 via lido, #211; neport beach, ca 92663, us CA 92663
• MDR Report Key: 9339271
• Report Number: 3005471919-2019-00079
• Device Sequence Number: 13921631
• Product Code: OHR
• UDI-Device Identifier: 00815947020505
• UDI-Public: (01)00815947020505(17)210628(10)18300102(241)HM14UK
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: ENFORCEMENT
• 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): 11/18/2019

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: 06/28/2021
• Device Model Number: HM14UK
• Device Catalogue Number: HM14UK
• Device Lot Number: 18300102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 11/18/2019
• 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