FDA.reportPublic FDA data

MAUDE MDR 8232172

MDR report key
8232172
Report number
3008061384-2018-00001
Event key
0
Event type
3
Date received
2019-01-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. ROBERT BALDACCI
Address
3629 REED CREEK DRIVE BASSETT VA 24055 US
Phone
866-866-8668
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SLEEPSAFESAFETY BEDSLEEPSAFE BEDSFNJSLEEPSAFERSR-MP-MG-T26068N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-0901. R

Event Narratives#

D

Patient 1

DME TECHNICIAN CALLS AND ALLEGES THE USER SUSTAINED A FINGER INJURY. THE USER CAUGHT THEIR FINGER(S) BETWEEN THE BACK PANEL GAP. DME TECHNICIAN ADVISED THAT THE PINS THAT SECURE PANEL-TO-PANEL WERE NOT INSTALLED. WITHOUT THE DOWEL PINS, THE PANELS CAN BE FLEXED APART OPENING A PINCH POINT. THE BED WAS ASSEMBLED IN THE HOME (B)(6) 2017. TECHNICIAN ADVISED THERE ARE NO WORK ORDER NOTES OR OTHER DOCUMENTATION THAT EXPLAIN WHY THE PINS WERE NOT INSTALLED. PRESUMABLY THEY WERE OMITTED ON INITIAL INSTALL OR POSSIBLE SUBSEQUENT MOVE. WE ARE OVERNIGHTING PINS FOR THE TECHNICIAN TO INSTALL. FOR PREVENTIVE ACTION, WE WILL PRE-INSTALL THE PINS BEFORE WE SHIP.