MAUDE Adverse Event Report: TEMPERATURE PROBE; THERMOMETER, ELECTRONIC, CLINICAL

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/23/2021

Event Type  Injury  

Event Description

During lap-sleeve procedure, the nasopharynges temperature probe migrated into the stomach and was subsequentially stapled into the staple line.The incision had to be reopened and temperature probe removed.Fda safety report id # (b)(4).

• Brand Name: TEMPERATURE PROBE
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• MDR Report Key: 12149763
• MDR Text Key: 261231303
• Report Number: MW5102452
• Device Sequence Number: 1
• Product Code: FLL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 52