PHANTOM XL INSULATED DILATORS ML-0441S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-15 for PHANTOM XL INSULATED DILATORS ML-0441S manufactured by Tedan Surgical Innovation Llc.

MAUDE Entry Details

Report NumberMW5089090
MDR Report Key8901668
Date Received2019-08-15
Date of Report2019-08-13
Date of Event2019-07-31
Date Added to Maude2019-08-16
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePHANTOM XL INSULATED DILATORS
Generic NameNEUROSUGICAL NERVE LOCATOR
Product CodePDQ
Date Received2019-08-15
Model NumberML-0441S
Catalog NumberML-0441S
Lot Number2019020501
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerTEDAN SURGICAL INNOVATION LLC


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-15

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