CEMENTED AEQUALIS INSTRUMENTATION SET YKAD22

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-15 for CEMENTED AEQUALIS INSTRUMENTATION SET YKAD22 manufactured by Tornier S.a.s..

Event Text Entries

[168624051] This is the initial report submitted regarding this surgical event and medical device.
Patient Sequence No: 1, Text Type: N, H10


[168624052] Upon opening up instruments in theatre it was discovered that the wrong trays had been dispatched to the hospital. The patient was already asleep and there were no sterile sets of the correct instruments in the area. Operation had to be cancelled and patient woken up. Patient was anesthesised and so had to be woken up without surgery having happened.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3000931034-2019-00139
MDR Report Key9193458
Date Received2019-10-15
Date of Report2019-09-16
Date of Event2019-09-16
Date Mfgr Received2019-09-18
Date Added to Maude2019-10-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS MAUD ANDRIOLLO
Manufacturer Street161 RUE LAVOISIER
Manufacturer CityMONTBONNOT SAINT-MARTIN, 38330
Manufacturer CountryFR
Manufacturer Postal38330
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCEMENTED AEQUALIS INSTRUMENTATION SET
Generic NameORTHOPEDIC TRAY
Product CodeOJH
Date Received2019-10-15
Catalog NumberYKAD22
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTORNIER S.A.S.
Manufacturer Address161 RUE LAVOISIER MONTBONNOT SAINT-MARTIN, 38330 FR 38330


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-10-15

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