MAUDE Adverse Event Report: SMARTMISSIMO TECHNOLOGIES PTE LTD POWERDOT; POWERED MUSCLE STIMULATOR

Model Number POWERDOT 2.0

Device Problem Electrical Shorting (2926)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported an event while using the duo product, which contains two device units.Both devices were returned for evaluation.The customer identified, and reported the issue regarding one device only.The reported event was confirmed; device performance tests showed high impedance in the suspect device.Inspection of the device identified that the magnetic button edge abnormally pierced the pcb and was in contact with the inner copper foil.This contact caused a short circuit resulting in abnormal output.The investigation also identified that the electrode pads were used beyond the use-life.This type of event will continue to be monitored.

Event Description

Customer reported that when using of one of his devices in the duo he experienced a burning sensation; customer reported that he had not experienced this issue with the other unit in the duo.Customer reported that when he removed the electrode pad he observed two burn marks on his back.The customer reported that the burn did not require medical attention, and that he self-treated with lotion.

• Brand Name: POWERDOT
• Type of Device: POWERED MUSCLE STIMULATOR
• Manufacturer (Section D): SMARTMISSIMO TECHNOLOGIES PTE LTD; 4 shenton way; #28-01 sgx centre ii; singapore central province 06880 7; SN 068807
• Manufacturer (Section G): ZMI ELECTRONICS, LTD; 6f-1 no. 286-4; shin ya rd; koahsiung 806 ; TW 806
• Manufacturer Contact: gabriela mccoole ; #28-01 sgx centre ii; 4 shenton way; SN 068807
• MDR Report Key: 10694422
• MDR Text Key: 211905150
• Report Number: 3012282682-2020-00003
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172876
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: POWERDOT 2.0
• Device Catalogue Number: DUORED2
• Device Lot Number: 1801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2020
• Initial Date Manufacturer Received: 10/04/2020
• Initial Date FDA Received: 10/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1