MAUDE Adverse Event Report: MMJ SA DE CV (USD) MON-A-THERM; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 90044

Device Problem Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during procedure, the unit's reading was lower than manual monitoring.There was no patient injury.

Manufacturer Narrative

This event has been reassessed and found to be a non-mdr reportable complaint.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MON-A-THERM
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desaroll; ciudad juarex 32590 ; MX 32590
• MDR Report Key: 8224340
• MDR Text Key: 132496421
• Report Number: 2936999-2019-00017
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 20884521031590
• UDI-Public: 20884521031590
• Combination Product (y/n): N
• PMA/PMN Number: K874514
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

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
• Device Operator: Health Professional
• Device Model Number: 90044
• Device Catalogue Number: 90044
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 01/07/2019
• Supplement Dates Manufacturer Received: 12/10/2018
• Supplement Dates FDA Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 YR
• Patient Weight: 11