N/A 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 1992-08-08 for N/A 26-1221 manufactured by Codman & Shurtleff, Inc..

Event Text Entries

[2340] Codman perforator plunged into dura rather than stopping. Device was recovered with original packing & retained by hospitaldevice 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 Number3005
MDR Report Key3005
Date Received1992-08-08
Date of Report1992-02-17
Date of Event1992-01-27
Date Facility Aware1992-02-17
Report Date1992-02-17
Date Reported to Mfgr1992-02-17
Date Added to Maude1993-04-05
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 NameDISPOSABLE PERFORATOR 14MM
Product CodeKAT
Date Received1992-08-08
Model NumberN/A
Catalog Number26-1221
Lot Number1H 805
ID NumberN/A
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Implant FlagN
Device Sequence No1
Device Event Key2808
ManufacturerCODMAN & SHURTLEFF, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1992-08-08

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