DISPOSABLE PERFORATOR 14MM WITH HUDSON END 26-1221

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-04-09 for DISPOSABLE PERFORATOR 14MM WITH HUDSON END 26-1221 manufactured by Codman.

Event Text Entries

[3475] Perforator jammed and did not stop when cranium drilled. Can result in a dural tear. Caused a dural tear and significant blood loss to patient. Device labeled for single use. Patient medical status prior to event: unknown. 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. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number5480
MDR Report Key5480
Date Received1993-04-09
Date of Report1993-03-11
Date of Event1993-03-04
Date Facility Aware1993-03-04
Report Date1993-03-11
Date Added to Maude1993-07-14
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 NameDISPOSABLE PERFORATOR 14MM WITH HUDSON END
Generic NamePERFORATOR
Product CodeHGE
Date Received1993-04-09
Model Number26-1221
Catalog Number26-1221
Lot NumberMJ8127
ID NumberH2022612211Y
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Implant FlagN
Device Sequence No1
Device Event Key5175
ManufacturerCODMAN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1993-04-09

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