N/A 84-42000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-21 for N/A 84-42000 manufactured by Xomed - Treace.

Event Text Entries

[2057] Surgical procedure being performed was an orbitial biopsy. When the surgeon activiated the x0med-treace cautery a spark was noted. Upon examination of the patient, it was noted by the physician that the patient had 1st and 2nd degree burns to the eyelid and the lower eyelashes had been singed offdevice labeled for single use. Patient medical status prior to event: satisfactory condition. There was not 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. Device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3083
MDR Report Key3083
Date Received1992-07-21
Date of Report1992-06-01
Date of Event1992-05-22
Date Facility Aware1992-05-22
Report Date1992-06-01
Date Reported to Mfgr1992-06-01
Date Added to Maude1993-04-06
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameN/A
Generic NameHIGH TEMP CAUTERY
Product CodeHQR
Date Received1992-07-21
Model NumberN/A
Catalog Number84-42000
Lot NumberUNKNOWN
ID NumberN/A
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Implant FlagN
Device Sequence No1
Device Event Key2884
ManufacturerXOMED - TREACE


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1992-07-21

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