FDA Adverse Event Injury Summary report: N

ESOPHAGEAL TEMPERATURE PROBE

MDR report key: 19510879 · Received June 10, 2024

Report

Report Number
MW5156098
Event Type
Injury
Date Received
June 10, 2024
Date of Event
May 22, 2024
Report Date
June 6, 2024
Manufacturer
CIRCA SCIENTIFIC, INC.
Product Code
FLL
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TN, US
Reporter Occupation
RISK MANAGER
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PROBE INSERTED INTO THE ESOPHAGUS BUT WOULD NOT READ OR REPOSITION. NEW PROBE OBTAINED, INSERTED, AND WORKED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
189518 ESOPHAGEAL TEMPERATURE PROBE THERMOMETER, ELECTRONIC, CLINICAL FLL CIRCA SCIENTIFIC, INC. CS-21EP 004677

Patients

Seq Age Sex Outcome Treatment
1 76 YR Male Required Intervention