FDA.reportPublic FDA data

MAUDE MDR 7143901

MDR report key
7143901
Report number
3003781275-2017-00002
Event key
0
Event type
3
Date of event
2017-11-07
Date received
2017-12-22
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#

Contact
MR. KEVIN WALLS
Address
33 GOLDEN EAGLE LANE LITTLETON CO 80127 US
Phone
720-720-7209
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ANDAGOPOWERED EXCERCISERHOCOMA AGBXBY N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-12-220

Event Narratives#

D

Patient 1

ONE CUSTOMER IN USA REPORTED A BROKEN HANDRAIL ON THE ANDAGO V2.0. (HANDRAILS ARE OPTIONAL COMPONENTS). IT OCCURED WHILE SERVICING THE MEDICAL DEVICE, NOT WHILE A THERAPY. NO PATIENT TRAINING ONGOING SO NOBODY (PATIENT, USER AND 3RD PERSONS) WERE INJURED. HOWEVER THE POTENTIAL HARM, COULD OCCUR DURING PATIENT SETUP AND RELEASE, WHICH COULD LEAD TO A SERIOUS INJURY. (SAFETY RELATED). AS THIS CASE IS RELATED TO PATIENT SAFETY, HOCOMA DECIDED TO INITIATE A MDR IN THE US. WE HAVE IDENTIFIED 19 (NINETEEN) ANDAGO V2.0 PRODUCTS IN USA.