FDA.reportPublic FDA data

MAUDE MDR 2245226

MDR report key
2245226
Report number
1282497-2011-00016
Event key
0
Event type
3
Date of event
2011-08-03
Date received
2011-09-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JANICE NEVIUS
Address
15 HAMPSHIRE STREET MANSFIELD MA 02048 US
Phone
508-508-5082
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
190043086 30009 HEAD REST 9" BAGELHEAD RESTANATOMIC CONCEPTSHBM3114313731143137UNKNOWN* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-09-0901. O

Event Narratives#

D

Patient 1

IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A HEAD REST. THE CUSTOMER REPORTS THE HEAD REST CAUGHT ON FIRE DURING SURGERY, WHILE USING 100% OXYGEN AND AN ES PENCIL (NOT MANUFACTURED BY COVIDIEN) RESULTING IN THREE FIRST DEGREE BURNS AT THE HAIRLINE. THE CUSTOMER REPORTS THAT THE BURNS ARE HEALING AND THAT THE PT SHOULD HAVE NOT SCARING. THE FIRE WAS IMMEDIATELY DOUSED WITH SALINE AND THE PT WAS TREATED WITH A COLD COMPRESS. THE CUSTOMER ALSO REPORTS THAT THIS DELAYED THE PROCEDURE DUE TO RE-PREPPING AND RE-DRAPING OF THE STERILE FIELD.

N

Patient 1

SUBMIT DATE: (B)(4) 2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.