MAUDE Adverse Event Report: CURE MEDICAL LLC CURE MEDICAL; URINARY CATHETER (INSERTION) TRAY

Model Number K2

Device Problem Device Issue (2379)

Patient Problem Urinary Tract Infection (2120)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

Investigation summary: event information was reported to manufacturer via a distributor.Distributer would not provide user's contact information nor perform additional follow-up on manufacturer's behalf so additional follow-up could not be initiated.Manufacturer is unable to directly confirm details of the event including if a dry bzk wipe was actually observed by the user or other potentially important details.No device was returned, so no evaluation could be performed on the actual device.Therefore the manufacturer is unable to confirm the reported product problem or if it may have caused or contributed to event.

Event Description

User experienced uti while using catheter insertion kit.User's mother asked if a dry bzk wipe may contribute to event.

• Brand Name: CURE MEDICAL
• Type of Device: URINARY CATHETER (INSERTION) TRAY
• Manufacturer (Section D): CURE MEDICAL LLC; 3700 newport blvd, ste 301; newport beach CA 92663 3946
• Manufacturer (Section G): SHAOXING FUQING HEALTH PRODUCTS CO., LTD.; no. 599 wuxie road; shaoxing high-tech industrial; shaoxing, zhejiang 31200 0; CH 312000
• Manufacturer Contact: scott stiles ; 3700 newport blvd. ste 301; newport beach, CA 92663-3946 ; 8005701778
• MDR Report Key: 6139205
• MDR Text Key: 61261818
• Report Number: 3005471919-2016-00008
• Device Sequence Number: 1
• Product Code: OHR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2017
• Device Model Number: K2
• Device Catalogue Number: K2
• Device Lot Number: 15B03802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other