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

Model Number	F16
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528); Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	08/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device failure did not occur during initial use.Failure occured after extended use.Device is cleared for intermittent bladder drainage, but was being used for continuous drainage while being continuously attached to urostomy bag (changed usually 1-2 times per week but sometimes less frequently).The off-label usage may have caused or contributed to device failure due to the potential for application of force magnitudes or modes beyond the intended use.Reserve and returned unused same-lot devices were evaluated and found to meet specifications.Manufacturing and quality control records did not reveal any issues with the lot.Actual device was not returned so root cause cannot be determined.No other similar reports received.
Event or Problem Description
While using intermittent catheter off-label as an indwelling catheter for stoma use, the funnel separated and the tubing was temporarily retained in the patient's stoma.The tubing was removed in the hospital.No injury was reported.

• 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: 6888544
• Report Number: 3005471919-2017-00003
• Device Sequence Number: 10886521
• Product Code: EZD
• UDI-Device Identifier: 00815947020222
• UDI-Public: (01)00815947020222(17)201028(10)161112-4(241)F16
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K072539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/22/2017

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: Nurse
• Device Expiration Date: 10/28/2021
• Device Model Number: F16
• Device Catalogue Number: F16
• Device Lot Number: 161112-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 09/22/2017
• 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: Required Intervention
• Patient Age: 88 YR