FDA.reportPublic FDA data

MAUDE MDR 3224306

MDR report key
3224306
Report number
MW5030850
Event key
0
Event type
3
Date of event
2012-10-24
Date received
2013-07-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GAYMAR ISOFLEX CRITICARE MATT MODEL MATTRESSMATTRESSSTRYKER CORPFMW2800100998

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-07-050

Event Narratives#

D

Patient 1

TO WHOM IT MAY CONCERN, IN REGARDS TO BELOW ISSUE, WE HAVE THE SAME MATTRESSES IN OUR FACILITY, AND WE ARE CONCERN WHAT THE NEXT STEP MIGHT BE IN RESOLVING THIS ISSUE. STRYKER REP HAS BEEN CONTACTED. PLEASE ADVISE, THANK YOU. IT WAS REPORTED BY SERVICE REPORT THAT THERE HAS BEEN FLUID INTRUSION TO THE INTERIOR MATTRESS. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.