FDA.reportPublic FDA data

MAUDE MDR 3259342

MDR report key
3259342
Report number
3259342
Event key
0
Event type
3
Date of event
2013-07-17
Date received
2013-07-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1*CHAIRINNOVATIVE PRODUCTS UNLIMITED, INCINBSAC22 P G/N/L** Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-07-260

Event Narratives#

D

Patient 1

PATIENT PLACED INTO BEDSIDE COMMODE (BSC), POSITIONED LEG IN ANTICIPATION OF PAINFUL SPASM, AND NURSING ASSISTANT TRIED TO ACCOMMODATE BY REPOSITIONING BSC. WHEN SHE REPOSITIONED, COMPONENTS OF PVC MATERIAL DISLODGED, CAUSING COLLAPSE OF CHAIR.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?BEDSIDE COMMODE FOR BOWEL MOVEMENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.