FDA.reportPublic FDA data

MAUDE MDR 2072694

MDR report key
2072694
Report number
MW5020401
Event key
0
Event type
3
Date of event
2010-10-10
Date received
2011-04-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
306
Health professional
3
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
1DEVICE, UNKNOWNLDQ N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-04-2501. D; 2. S

Event Narratives#

D

Patient 1

MY MOTHER DID IN FACT HAVE OTHER ILLNESSES AT THE TIME OF THIS INCIDENT, BUT SHE ALSO HAD THIS DEVICE PUT IN AND AT THE TIME, SHE WAS DOING VERY WELL, HER BREATHING WAS IN FACT GETTING BETTER AND HER ILLNESSES WERE STABLE. BUT HER BREATHING GOT SERIOUSLY WORSE ABOUT TWO DAYS AFTER THIS DEVICE WAS PUT IN. THEN ABOUT A WEEK AFTER THE DEVICE WAS IN, SHE GOT PUT IN ICU AND THEN TWO TO THREE DAYS LATER, SHE PASSED AWAY. I TOTALLY BELIEVE THAT THIS DEVICE DID IN FACT CAUSE HER DEATH AND I DO INTEND ON PURSUING A LAWSUIT NOW THAT I KNOW THAT THIS DEVICE HAS HAD OTHER PROBLEMS AND IS NOW BEING RECALLED.