MAUDE Adverse Event Report: BIOVENTUS LLC BIOVENTUS EXOGEN ULTRASOUND GEL; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP

Catalog Number 62535449

Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303)

Patient Problems Rash (2033); Fungal Infection (2419); Ambulation Difficulties (2544); Tissue Breakdown (2681)

Event Date 12/02/2020

Event Type  Injury  

Event Description

Patient called to report a recall and adverse reaction to bioventus exogen ultrasound gel she used for a true jones fracture.Patient stated that on (b)(6) 2020, while at her doctor's office, she was given bioventus exogen ultrasound gel to help with her fracture.Patient stated that by (b)(6) 2020, she noticed the bottoms of her feet were showing signs of a rash.Patient stated from the boot down, her skin was broken down and the rash on the bottoms of her feet got so bad it prevented her from walking some days.Patient stated at a doctor visit it was discovered it was a fungal bacteria covering the bottoms of her feet.Patient said in (b)(6) she received a recall letter from bioventus dated 12/14/2020, stating that multiple lots of the exogen gel may be contaminated and that a recall had been issued.Patient stated she still has the device.Patient stated she's used the exogen ultrasound gel 419 times, twice a day for 50 days as prescribed to her.

• Brand Name: BIOVENTUS EXOGEN ULTRASOUND GEL
• Type of Device: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 11195290
• MDR Text Key: 227995377
• Report Number: MW5098874
• Device Sequence Number: 1
• Product Code: IMG
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 62535449
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR