MAUDE MDR 5261448

MDR report key
5261448
Report number
3004141004-2015-00001
Event key
0
Event type
3
Date of event
2015-07-29
Date received
2015-10-21
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#

Address
NO.144 DONG MING RD. TAJIA DIST. TAICHUNG CITY, R.O.C. TW
Phone
426-426-4268
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RIO MOBILITYDRAGONFLY MANUAL WHEELCHAIR HAND CYCLE ATTACHMENTRIO MOBILITYKNO8-HR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-10-2101. S

Event Narratives#

N

Patient 1

BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT (B)(4) DETERMINED THE DRAGONFLY DID NOT FAIL AND DECIDED NOT TO HAVE THE USER RETURN IT FOR TESTING. (B)(4) WAS ABLE TO SIMULATE THE EVENT USING A DRAGONFLY FROM STOCK. TEST 1: TESTED THE DRAGONFLY OUTSIDE AND RECREATED THE EVENT DESCRIBED BY THE COMPLAINT. WHEN LOOSING CONTROL OF THE DRAGONFLY, WE WERE ABLE TO REGAIN IT AGAIN BY LETTING THE DRAGONFLY ROLL BACK AND NATURALLY SWERVE TO THE RIGHT AND ENGAGING THE SECONDARY BRAKE LOCATED IN FRONT OF THE DRAGONFLY. TEST 2: ASSESSED THE ENTIRE DRAGONFLY AND SIMULATED A HAND SLIPPING BETWEEN THE CHAIN AND SPROCKET GUARD. WE DETERMINED THE SPOT BETWEEN THE CHAIN AND SPROCKET GUARD IS A PINCH POINT AND SHOULD EITHER BE COVERED OR LABELED AS A PINCH POINT. CONCLUSION: IT HAS BEEN CONCLUDED THE COMBINATION OF THE FOLLOWING RESULTED IN THE USER'S INJURY: USER ERROR, PINCH POINT BETWEEN THE DRAGONFLY CHAIN AND SPROCKET GUARD AND CONTEXT OF THE EVENT.

D

Patient 1

COMPLAINANT EMAILED (B)(4) TO REPORT HIS HUSBAND (USER) WAS INJURED WHILE USING THE DRAGONFLY FOR THE FIRST TIME. THE COMPLAINANT STATED THE USER CAME TO A COMPLETE STOP ON A HILL TO SHIFT GEARS THEN PROCEEDED TO LOSE CONTROL OF THE DRAGONFLY. THE USER PANICKED AND TRIED TO REGAIN CONTROL BY ATTEMPTING TO GRAB THE PEDALS. IN THE PROCESS OF TRYING TO REGAIN CONTROL, THE USER GRABBED THE SPROCKET GUARD WITH HIS RIGHT HAND AND HIS RIGHT INDEX FINGER WAS PINCHED BETWEEN THE SPROCKET GUARD AND CHAIN RESULTING IN A BROKEN TENDON AND TORE UP SKIN. COMPLAINANT INDICATED IN A PHONE CONVERSATION AND IN AN EMAIL THAT THE USER ELECTED NOT TO HAVE SURGERY DUE TO THE FACT THAT HE IS A FULL TIME WHEELCHAIR USER AND THE RECOVERY TIME IS TOO LONG. REF# MW5055545.