MAUDE MDR 7725809

MDR report key
7725809
Report number
MW5078660
Event key
0
Event type
3
Date of event
2018-07-14
Date received
2018-07-26
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
306
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
0REMOVAL OF BEDRAILSBED, MANUALUNKFNJNONENONEI Y
1REMOVAL OF BEDRAILSBED, MANUALUNKFNJNONENONEI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-07-2601. S

Event Narratives#

D

Patient 1

BECAUSE OF MY FDA RULES TO REMOVE THE RAILS FROM NURSING HOME BEDS, MY MOTHER RECENTLY BROKE HER LEG IN 2 PLACES. SHE HAS HAD 6 SURGERIES ON THIS LEG AND IS NOW (B)(6). NOW SHE HAS TO SUFFER FURTHER WITH A BROKEN LEG. IT WASN'T BAD ENOUGH THAT SHE IS STUCK IN THE NURSING HOME BUT NOW I AM GREETED WITH WHY ME QUESTIONS, WHEN IT DIDN'T NEED TO BE. WHAT WAS THE FDA THINKING, HOSPITALS STILL HAVE BED WITH RAILS. HER QUALITY OF LIFE HAS GONE DOWNHILL INFINITELY. NOT EVERY PT/RESIDENT SHOULD BE AS MOM HAS STATED: "I FEEL LIKE I'M SLEEPING IN A HOLE." THE SITUATION THE FDA CREATED IS LUDICROUS AS IF EVERYONE FITS YOUR SQUARE BOX IN HEALTH ISSUES, WE DONT AND YOU NEED TO REVERSE THIS ACTION AND ADD FLEXIBILITY. THE MINUTE OF MY BROTHER AND I (GUARDIAN) SAW THIS CONFIGURATION WE KNEW THIS WOULD HAPPEN. IT'S TOO BAD THE FDA DIDN'T SEE FORWARD PAST WHAT A MISTAKE, IT REALLY WAS.