MAUDE MDR 8569260

MDR report key
8569260
Report number
MW5086300
Event key
0
Event type
3
Date of event
2019-04-12
Date received
2019-04-30
Adverse event
3
Product problem
3
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
1BED BY GEORGE DREAM SERIES FULL SIZE HIGH-SIDE SAFETY BED WITH CANOPYBED MANUALBEDS BY GEORGEFNJ2700I Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-3001. O; 2. R

Event Narratives#

D

Patient 1

CONSUMER WAS PLACED IN HER BEDS BY GEORGE FULL SIZED DREAM SERIES 2700 SAFETY BED FOR SLEEP AS USUAL. SHE HAD BEEN SLEEPING IN THE NEW BED SINCE IT WAS DELIVERED MID (B)(6) 2019. ABOUT 0530 IN THE MORNING, MOM HEARD A REPETITIVE SOUND LIKE SOMEONE WAS KICKING A DOOR. WENT TO INVESTIGATE WHERE IT WAS COMING FROM. ENDED UP ACROSS THE HALL IN (B)(6) ROOM. LOOKED IN HER SAFETY BED AND SHE WAS NOT VISIBLE. UPON CLOSER INSPECTION, THE MATTRESS APPEARED ELEVATED. THE KICKING SOUND WAS STILL BEING HEARD. MOM RELEASED THE SIDE RAIL AND FOUND (B)(6) AWAKE AND UNDERNEATH THE MATTRESS. (B)(6) CLIMBED OUT WITH ASSISTANCE. NO VISIBLE INJURIES. SHE WAS FULLY AWAKE AND CONSCIOUS. NOTIFIED BEDS BY GEORGE EMPLOYEE (B)(6). (B)(6) REQUESTED BED MEASUREMENTS AND EXTENSIVE PHOTOGRAPHS. HE REFUSED TO SEND A BEDS BY GEORGE EMPLOYEE IN PERSON TO LOOK AT THE BED WHEN PARENTS REQUESTED IT. HE DETERMINED SOLELY FROM PHOTOGRAPHS THAT THE MATTRESS WAS TOO SMALL FOR THE BED FRAME AND NEEDED TO BE MEDICAL GRADE FOAM NOT INNERSPRING. (B)(6) STATED THAT A NEW CUSTOM-SIZED (LARGER) MEDICAL-GRADE FOAM MATTRESS WOULD BE SENT TO CONSUMER'S HOME ASAP AND WITHIN THE WEEK. TWO WEEKS HAVE PASSED AND NO REPLACEMENT MATTRESS RECEIVED TO DATE. ENTRAPMENT OF CONSUMER. FDA SAFETY REPORT ID# (B)(4).