MAUDE Adverse Event Report: BTL INDUSTRIES JSC EMSELLA BTL; STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE

Patient Problems Bruise/Contusion (1754); Pain (1994); Ambulation Difficulties (2544); Electric Shock (2554); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559)

Event Date 08/19/2023

Event Type  Injury  

Event Description

I used btl machine called emsella.It damaged my muscles permanently, entire pelvic floor, ham[invalid], adductors and glutes including muscles, smashing them and injuring nerves.The signal had travelled as far as my hands, chest, breast, neck, face, and head.In fact i am worried that the electric coil was broken and instead of electromagnetic signal it was delivered electric signal and electrocuted my entire body.All muscles shortened some were injured and bruised where the signal was tapping directly, entire vagina is damaged, i have burning pain inside pelvis in vagina, it damaged my ham[invalid], i cannot walk, this is sham and scam technology unless the provider used it wrongly.Ear disapprove it.I have used it london uk but want to warn you about it.Btl (i used it in (b)(6).Weak pelvic floor muscles wanted to improve but damaged all muscles for life).

• Brand Name: EMSELLA BTL
• Type of Device: STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): BTL INDUSTRIES JSC
• MDR Report Key: 18399550
• MDR Text Key: 331497011
• Report Number: MW5149580
• Device Sequence Number: 1
• Product Code: KPI
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: DIAZEPAM FOR RELAXING DAMAGED MUSCLES.; ORAL MORFINE WHICH I HAVE TO USE SINCE THE SHAN TREATMENT.; PARACETAMOL.
• Patient Outcome(s): Other; Disability
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White