SIMPLATE II UNKNOWN 286-618

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-31 for SIMPLATE II UNKNOWN 286-618 manufactured by Organon Teknita Corporation.

Event Text Entries

[1900] On april 22, 1992, use of implate left two gaping wounds rsther than small incisionsinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding 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. Imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4182
MDR Report Key4182
Date Received1992-07-31
Date of Report1992-07-31
Date of Event1992-04-22
Report Date1992-07-31
Date Added to Maude1993-05-14
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 NameSIMPLATE II
Generic NameBLEEDING TIME DEVICE
Product CodeJCA
Date Received1992-07-31
Model NumberUNKNOWN
Catalog Number286-618
Lot Number100853
ID NumberUNKNOWN
OperatorOTHER HEALTH CARE PROFESSIONAL
Device Availability*
Implant Flag*
Device Sequence No1
Device Event Key3915
ManufacturerORGANON TEKNITA CORPORATION


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1992-07-31

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