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

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

Patient Problem Bacterial Infection (1735)

Event Type  malfunction  

Event Description

It was reported that the patient had a staph infection which had spread throughout the body.(b)(6).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: 17531583
• MDR Text Key: 321183620
• Report Number: MW5138496
• 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: 08/12/2020

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