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

Model Number	ULTRA M16C
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	05/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient (user) reported he contracted a urinary tract infection (uti).He reported he thinks he got a uti due to the device packaging being difficult for him to open.It only tore half way across the top so he had difficulty getting the catheter out.As a result, he thinks he had to touch the catheter more than usual, thereby possibly contaminating the catheter in the process.His doctor prescribed nitrofurantoin (100mg, 3 x day) for 10 days.He took the medication and recovered completely.

• Brand Name: CURE MALE ULTRA
• Common Device Name: URINARY CATHETER
• Manufacturer (Section D): CURE MEDICAL LLC; 3471 via lido, #211; newport beach CA 92663
• MDR Report Key: 7858171
• Report Number: 3005471919-2018-00027
• Device Sequence Number: 19167047
• Product Code: KOD
• UDI-Device Identifier: 00815947021120
• UDI-Public: (01)00815947021120(17)200928(10)171005-3(241)ULTRAM16C
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K080881
• 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): 09/07/2018

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: 09/28/2020
• Device Model Number: ULTRA M16C
• Device Catalogue Number: ULTRA M16C
• Device Lot Number: 171005-3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 09/07/2018
• 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: 79 YR
• Patient Weight: 75