MAUDE Adverse Event Report: MMJ SA DE CV(USD) MON-A-THERM; CATHETER, UROLOGICAL

Model Number	90056
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the catheter was not continuous, no urine could run through the tube.It was indicated that the patient was in septic shock, there was no urine monitoring possible.The catheter was checked, and it could not be rinsed or aspirated.It was also reported that the overall condition of the patient could have been worsened due to abnormal discharge, possibly that the urine goes back to the kidneys.

• Brand Name: MON-A-THERM
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): MMJ SA DE CV(USD); ave henequen no 1181 desarrol; ciudad juarez,mx 32590 ; MX 32590
• MDR Report Key: 7888955
• Report Number: 2936999-2018-00590
• Device Sequence Number: 2725570
• Product Code: KOD
• UDI-Device Identifier: 30884521077595
• UDI-Public: 30884521077595
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K831567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2023
• Device Model Number: 90056
• Device Catalogue Number: 90056
• Device Lot Number: 18D0343JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 09/19/2018
• 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: 67 YR