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

Model Number	90051
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
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 device had a false measurement of temperature, wherein the catheter temperature was 36.4 and in the control rectally 39.5, then a further temperature control was performed in the groin with a result of 39.0.No reported patient outcome.

• 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: 7814358
• Report Number: 2936999-2018-00536
• Device Sequence Number: 16200274
• Product Code: KOD
• UDI-Device Identifier: 30884521078028
• UDI-Public: 30884521078028
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Type of Report: Initial
• Report Date (Section B): 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2023
• Device Model Number: 90051
• Device Catalogue Number: 90051
• Device Lot Number: 18A0142JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 08/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1