MAUDE Adverse Event Report: ORTHOFIX ACCELSTIM; BONE GROWTH STIMULATOR

Model Number 4300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

This incident is related to a skin irritation problem.Konix gel k101952 is a component of the device.There were no dysfunction, deficiencies/deteriorations found with the device.No device malfunction has occurred.The review has determined that the risk assessment is still adequate.

Event Description

Information provided states that patient was prescribed accelstim device (b)(6) 2022.Pt said she only used it 3-4 times.After last treatment red burns appeared about the size of the device on her foot, 2-3 burns on the back bottom of her foot where the device was and on the top of the foot.She stopped using the device.Patient said the burns have since healed.Pt stated she tried alternative mineral oil and glycerin with the same results.

• Brand Name: ACCELSTIM
• Type of Device: BONE GROWTH STIMULATOR
• Manufacturer (Section D): ORTHOFIX; 3451 plano parkway; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX; 3451 plano parkway; lewisville TX 75056
• Manufacturer Contact: james stephens ; 3451 plano parkway; lewisville, TX 75056 ; 4698913525
• MDR Report Key: 17059858
• MDR Text Key: 316585754
• Report Number: 2183449-2023-00001
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 08050040997213
• UDI-Public: 08050040997213
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P210035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4300
• Device Catalogue Number: 654300-0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Sex: Female