RECTAL THERMOMETER 2000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-06-30 for RECTAL THERMOMETER 2000 manufactured by Ivac.

Event Text Entries

[18482517] On may 15, 1992, we we caring for an eighth (8) month old infant in the emergency department. The nurse took a rectal temperature with an ivac thermometer. The probe cover became detachefd from the electronic stylet and was subsequently retracted into the infant's rectum. The probe was eventually recovered with the patient under general anesthesia another facilityinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4407
• MDR Report Key: 4407
• Date Received: 1992-06-30
• Date of Report: 1992-05-22
• Date of Event: 1992-05-15
• Report Date: 1992-05-22
• Date Added to Maude: 1993-05-24
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RECTAL THERMOMETER
• Generic Name: PROBE
• Product Code: EXX
• Date Received: 1992-06-30
• Model Number: 2000
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 4131
• Manufacturer: IVAC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-06-30