FDA.reportPublic FDA data

MAUDE MDR 9654285

MDR report key
9654285
Report number
MW5092673
Event key
0
Event type
3
Date of event
2017-03-20
Date received
2020-01-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
600
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
1RAZ REHAB SHOWER CHAIR (HCPCS #E0240)CHAIR, ADJUSTABLE MECHANICALRAZ DESIGN INC.INNSPI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-3001. H; 2. S

Event Narratives#

D

Patient 1

WHILE (B)(6) WAS SHOWERING USING THE SHOWER CHAIR ON (B)(6) 2017, THE SEAT COMPLETELY GAVE WAY, COLLAPSING AND CAUSING ONE OF THE STAINLESS STEEL RODS THAT SUPPORT THE SEAT TO IMPALE HIS ANUS AND COLON. HIS COLON WAS PERFORATED IN SIX DIFFERENT PLACES. THIS WIRE REMOVED THE ROD FROM HIS RECTUM BEFORE EMERGENCY RESPONDERS ARRIVED.