MAYFIELD SWIVEL HORSESHOE HEADREST A1012

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06 report with the FDA on 2009-05-18 for MAYFIELD SWIVEL HORSESHOE HEADREST A1012 manufactured by .

Event Text Entries

[1259712] Reporter stated, the product slips with the pt in the holder. No injury to the pt.
Patient Sequence No: 1, Text Type: D, B5


[8314702] To date, the device involved in the reported incident has been received for evaluation. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004608878-2009-00023
MDR Report Key1461433
Report Source04,06
Date Received2009-05-18
Date of Report2009-05-18
Date Facility Aware2009-04-20
Date Added to Maude2009-11-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactSHANNON DAVID
Manufacturer Street315 ENTERPRISE DR.
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMAYFIELD SWIVEL HORSESHOE HEADREST
Generic NameNA
Product CodeHBM
Date Received2009-05-18
Catalog NumberA1012
Lot Number977
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2009-05-18

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