FDA.reportPublic FDA data

MAUDE MDR 6710332

MDR report key
6710332
Report number
1531186-2017-00011
Event key
0
Event type
3
Date of event
2017-04-28
Date received
2017-07-13
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#

Address
US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SUCTION CUP GRAB BAR 9153651509AID, TRANSFERDONGGUAN CHUANGGUOIKX222-3SC141230N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-1301. D; 2. H

Event Narratives#

N

Patient 1

THE PATIENT'S DAUGHTER-IN-LAW STATED THAT SHE PURCHASED THE GRAB BAR FOR THE PATIENT APPROXIMATELY ONE YEAR AGO, AND HE HAD BEEN USING IT SINCE THAT TIME. SHE STATED THAT THE PATIENT LIVED IN AN APARTMENT, AND THE TUB/SHOWER HAS A FIBERGLASS TUB SURROUND. THE ALLEGATION THAT THE GRAB BAR CAUSED THE PATIENT TO FALL IS THE OPINION OF THE PATIENT'S DAUGHTER-IN-LAW. THERE WERE NO WITNESSES PRESENT WHEN THE PATIENT FELL, AND NO STATEMENT WAS PROVIDED FROM THE PATIENT VERIFYING WHAT TOOK PLACE. IT CANNOT BE CONFIRMED WHAT CAUSED THE PATIENT TO FALL OR WHAT CAUSED THE GRAB BAR TO ALLEGEDLY COME OFF OF THE SHOWER WALL. THE EXTENT OF THE INJURY WAS NOT REPORTED, AND IT IS UNKNOWN FROM WHERE THE PATIENT WAS BLEEDING. THE CAUSE OF DEATH WAS ALSO NOT PROVIDED, SO IT IS UNCLEAR IF THE INJURIES FROM THE FALL LED TO THE PATIENT?S DEATH OR IF THERE WERE OTHER FACTORS INVOLVED, AS THE PATIENT WAS LEFT UNATTENDED FOR TWO DAYS. AT THIS TIME, A DEVICE MALFUNCTION CANNOT BE CONFIRMED. THE GRAB BAR WAS RETURNED TO INVACARE ON JUNE 28, 2017 AND THE EVALUATION IS IN-PROCESS. THE 222-3 GRAB BAR IS AN IMPORTED PRODUCT WITH MULTIPLE POTENTIAL SUPPLIERS. IT IS UNKNOWN WHICH MANUFACTURER SUPPLIED THIS PARTICULAR GRAB BAR TO INVACARE, AS THE DATE CODE WAS NO LONGER PRESENT ON THE DEVICE. THE SUCTION CUP GRAB BARS USER MANUAL STATES, "THE GRAB BAR PROVIDES SUPPORT AND INCREASES STABILITY FOR AN INDIVIDUAL. THE GRAB BAR IS NOT DESIGNED TO SUPPORT THE FULL WEIGHT OF AN INDIVIDUAL. ALWAYS CHECK THAT THE GRAB BAR IS SECURED TO THE WALL BEFORE USE. USE EXTREME CAUTION ON WET TUB OR FLOOR SURFACES."

D

Patient 1

THE PATIENT'S DAUGHTER-IN-LAW REPORTED THAT ON (B)(6) 2017 THE PATIENT WAS USING THE 222-3 GRAB BAR WHILE SHOWERING, AND WHEN HE WENT TO USE THE GRAB BAR IT CAME OFF THE TUB ENCLOSURE AND HE FELL. THE PATIENT LAID IN THE TUB/SHOWER FOR A COUPLE DAYS BEFORE HE WAS FOUND ON (B)(6) 2017; HE WAS STILL ALIVE BUT THERE WAS BLOOD ALL OVER. HE WAS TAKEN TO THE HOSPITAL AND WAS IN INTENSIVE CARE FOR A WEEK, AND THEN HE PASSED AWAY ON (B)(6) 2017.

N

Patient 1

THE EVALUATION OF THE 222-3 GRAB WAS COMPLETED ON 07/27/2017. DURING THE EVALUATION, IT WAS IDENTIFIED THAT THE DATE CODE WAS PRESENT AT THE END OF THE GRAB BAR UNDERNEATH THE LEVER. THE DATE CODE INDICATES THAT THIS 222-3 GRAB BAR WAS MANUFACTURED BY (B)(4) (HOME MEDICAL PRODUCTS INC.). DURING THE EVALUATION, THE REPORTED ISSUE OF THE GRAB BAR COMING OFF THE TUB ENCLOSURE WAS NOT ABLE TO BE DUPLICATED. THE GRAB BAR WAS ABLE TO BE SECURELY MOUNTED TO A FIBERGLASS TUB SURFACE AND WAS ABLE TO SUPPORT A DOWNWARD STATIC LOAD OF 66 POUNDS, WHICH IS THE MAXIMUM LOAD SPECIFIED IN THE SUCTION CUP GRAB BARS USER MANUAL. THE WINDOW AT EACH END OF THE GRAB BAR TURNED FROM RED TO GREEN WHEN THE GRAB BAR WAS MOUNTED TO THE TUB WALL AND THE LEVERS WERE LOWERED, WHICH INDICATES THAT THE GRAB BAR WAS SECURELY MOUNTED TO THE WALL. THERE WERE NO DEFECTS WITH THE DEVICE WHICH PREVENTED ADEQUATE MOUNTING OR STABILITY. THERE HAVE BEEN (B)(4) OF MODEL 222-3 GRAB BARS SOLD BY INVACARE WITHIN THE PAST 2 YEARS. WITHIN THE SAME TIME PERIOD, THERE HAVE BEEN NO OTHER ADVERSE EVENTS REPORTED IN ASSOCIATION WITH THIS DEVICE. AS THIS WAS AN ISOLATED INCIDENT AND A DEVICE MALFUNCTION WAS NOT CONFIRMED DURING TESTING, THE REPORTED DEATH WAS LIKELY THE RESULT OF AN ACCIDENT.