MAUDE Adverse Event Report: ORTHOFIX MEDICAL INC BONE GROWTH STIMULATOR; PHYSIOSTIM

Model Number 5302

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

Patient Problems Burn(s) (1757); Discomfort (2330)

Event Date 11/03/2020

Event Type  Injury  

Event Description

Information provided states that patient had surgery on (b)(6) 2020 to repair a displaced fracture of fifth metatarsal in her right foot.Patient began treating 3 hours per day with physiostim device from (b)(6) 2020 to (b)(6) 2020.Patient experienced discomfort and removed bandages.Patient believes that the physiostim unit had burned her foot.Patient contacted surgeon and was admitted to hospital for iv antibiotic treatments for 2 days.

• Brand Name: BONE GROWTH STIMULATOR
• Type of Device: PHYSIOSTIM
• Manufacturer (Section D): ORTHOFIX MEDICAL INC; 3451 plano parkway; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX MEDICAL INC; 3451 plano parkway; lewisville TX 75056
• Manufacturer Contact: yolanda thompson ; 3451 plano parkway; lewisville, TX 75056 ; 2149372291
• MDR Report Key: 10955637
• MDR Text Key: 219963442
• Report Number: 2183449-2020-00010
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 18257200131969
• UDI-Public: 18257200131969
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850007
• 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
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5302
• Device Catalogue Number: 655302-0001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2020
• 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: 44 YR