UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-05 for UNKNOWN manufactured by Welch/allen Bulb.

Event Text Entries

[1764] The bulb of the straight blade largnposcope came out while atrtempting to intubate a patientdevice labeled for single use. Patient medical status prior to event: critical 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: maybe. Corrective actions: other. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2137
MDR Report Key2137
Date Received1993-01-05
Date of Report1992-01-25
Date of Event1992-01-25
Date Facility Aware1992-01-25
Report Date1992-01-25
Date Reported to FDA1992-01-25
Date Added to Maude1993-01-14
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 NameUNKNOWN
Generic NameUNKNOWN
Product CodeFFY
Date Received1993-01-05
Model NumberUNKNOWN
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
ID NumberUNKNOWN
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityN
Implant FlagN
Device Sequence No1
Device Event Key1982
ManufacturerWELCH/ALLEN BULB


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1993-01-05

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