EZ STRETCH A-70

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-23 for EZ STRETCH A-70 manufactured by Full Range Rehab, Llc.

Event Text Entries

[101055384] The patient was prescribed an ez stretch device to extend the range of motion in his knee following knee surgery in (b)(6) 2017. A device was delivered to his home on (b)(6) 2017 and was picked up on (b)(6) 2017. The patient also attended rehab sessions with his physical therapist, (b)(6), at (b)(6) medical center, where he used the ez stretch device there (serial # (b)(4)). The patient informed a full range rehab service rep on (b)(6) 2017 that his "numbers" on the ez stretch were 0/100 (degrees of extension/flexion), and asked to extend the use of the device for another month. Sometime after (b)(6) 2017, the patient met with his physical therapist, (b)(6), at (b)(6) medical center. The physical therapist sat the patient on the device and the physical therapist operated the controls of the device himself. The physical therapist took the patient to a much farther degree of flexion than the patient had previously been reaching on his own. The patient protested vehemently and told the physical therapist he was in horrible pain. The physical therapist responded "i'm the therapist here. " the physical therapist instructed the patient to hold the stretch for 25 minutes. The patient insisted that he had been instructed by the full range rehab that he was only supposed to use the ez stretch device in five minute increments. The physical therapist replied in a joking manner, "i'm the therapist here, 25 minutes. " and did not stop or reduce the stretch. After the above physical therapy session the patient was in significant pain and all rehab progress stopped. The patient stated up until the above physical therapy session that he had been progressing well and liked using the ez stretch. The patient then made an appointment with his orthopedic surgeon, dr. (b)(6). The doctor performed a physical exam and took x-rays. His findings were that the patient suffered torn ligaments and a dislocated patella. When the doctor couldn't explain how these injuries occurred, the patient then reluctantly told him about the physical therapy session where the adverse event occurred. The doctor acknowledged the physical therapist should not have instructed the patient to hold the stretch for 25 minutes, nor should the physical therapist have operated the device. Dr. (b)(6) performed reconstructive surgery in (b)(6) 2017 to repair ligaments and replace the patella for the patient. This adverse event occurred at the (b)(6) medical center in (b)(6) 2017. It was not reported or otherwise learned of by full range rehab until (b)(6) 2017. The ez stretch device located at (b)(6) medical center was used routinely after the adverse event, with no additional known instance of injury or malfunction. After (b)(6) 2017 the ez stretch located at (b)(6) medical center was serviced by a full range rehab service rep. The service rep did not note any malfunction of the device or damage to it. No corrective actions appeared to be needed by the device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5075514
MDR Report Key7295950
Date Received2018-02-23
Date of Report2018-02-13
Date of Event2017-06-01
Date Added to Maude2018-02-26
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameEZ STRETCH
Generic NameRANGE OF MOTION MACHINE FOR KNEE (EZ STRETCH)
Product CodeBXB
Date Received2018-02-23
Model NumberA-70
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerFULL RANGE REHAB, LLC
Manufacturer AddressCINCINNATI OH US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2018-02-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.