MAUDE Adverse Event Report: BOBBITO MASSAGE GUN; MASSAGER, THERAPEUTIC, ELECTRIC

BOBBITO MASSAGE GUN; MASSAGER, THERAPEUTIC, ELECTRIC

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2023

Event Type malfunction

Event Description

While charging an old model of bobbito massage gun, the battery caught fire.No patients were involved with the device at the time of the fire.

1 Device was Involved in the Event
Brand Name	BOBBITO MASSAGE GUN
Type of Device	MASSAGER, THERAPEUTIC, ELECTRIC
MDR Report Key	17498844
MDR Text Key	320784667
Report Number	MW5122872
Device Sequence Number	1
Product Code	ISA
Combination Product (y/n)	N
Reporter Country Code	US
Number of Events Reported	1
Summary Report (Y/N)	N
Report Source	Voluntary
Reporter Occupation	Risk Manager
Type of Report	Initial
Report Date	08/08/2023
1 Patient was Involved in the Event
Is this an Adverse Event Report?	No
Is this a Product Problem Report?	Yes
Device Operator	Health Professional
Was Device Available for Evaluation?	No
Is the Reporter a Health Professional?	Yes
Initial Date Manufacturer Received	Not provided
Initial Date FDA Received	08/09/2023
Is This a Reprocessed and Reused Single-Use Device?	No
Patient Sequence Number	1
Patient Outcome(s)	Other;