CODMAN DISPOSABLE PERFORATOR 26-1221 14MM 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 1992-07-09 for CODMAN DISPOSABLE PERFORATOR 26-1221 14MM 26-1221 manufactured by Codman - J&j.

Event Text Entries

[1604] Disposable sizngle use only perforator broke while in use resulting in puncture of dura. Slight contusion brain surfacedevice labeled for single use. Patient medical status prior to event: fair 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 evaluated after the event. Method of evaluation: actual device involved in incident was evaluated. Results of evaluation: component failure. Conclusion: device failure occurred and was related to event, device failure directly caused event, device failure directly contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service, device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4537
MDR Report Key4537
Date Received1992-07-09
Date of Report1992-02-27
Date of Event1992-02-21
Date Facility Aware1992-02-21
Report Date1992-02-27
Date Reported to FDA1992-02-27
Date Reported to Mfgr1992-02-27
Date Added to Maude1993-05-26
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 NameCODMAN DISPOSABLE PERFORATOR
Generic NameDISPOSABLE NEURO PERFORATOR
Product CodeKAT
Date Received1992-07-09
Model Number26-1221 14MM
Catalog Number26-1221
Lot NumberLH802
ID NumberLH 8023 H202261221114
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Implant FlagN
Device Sequence No1
Device Event Key4256
ManufacturerCODMAN - J&J


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1992-07-09

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