MAUDE Adverse Event Report: UNKNOWN UNKNOWN BONE GROWTH STIMULATOR; STIMULATOR, BONE GROWTH, NON-INVASIVE

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Reaction to Medicinal Component of Device (4574)

Event Type  Injury  

Event Description

The patient reported that when their bone growth stimulator was turned on, the patient was getting a painful reaction with orthofix.It was also reported that it felt like the stimulation was too high and that it was pretty strong.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN BONE GROWTH STIMULATOR
• Type of Device: STIMULATOR, BONE GROWTH, NON-INVASIVE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17530539
• MDR Text Key: 321090425
• Report Number: MW5137458
• Device Sequence Number: 1
• Product Code: LOF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1