MAUDE Adverse Event Report: XI AN BELLAVIE AND SUNBRIGHT GROUP CO.,LTD. MIGHTY BLISS; HEATING PAD

Model Number NA-H21B

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Customer complaint - limited data available: "i have a heating pad that is zapping me with shocks.I have checked the recall and my model isn't listed on the recall.I called in to the recall number over 6 months ago and was told this complaint would be funneled up through an escalation process and i would get an email back.I have yet to receive any communication and called in again today and went through the same exact "escalation" process.Can i please find out what i need to do?" information obtained from email correspondence: additional details about how the product was being used at that time and what happened - "it gives out zaps/shocks while on and on a body part.It's nothing severe or intense; more surprising and annoying than painful." was any medical treatment necessary? if so, please provide additional details - "no.Incident date or first date issue was observed - "soon after purchasing but i don't use it very often, the last time i used it, i was in bed and my husband felt it and said, that's not safe! ".

• Brand Name: MIGHTY BLISS
• Type of Device: HEATING PAD
• Manufacturer (Section D): XI AN BELLAVIE AND SUNBRIGHT GROUP CO.,LTD.; 4-1101, taihua jinmao; intl plaza, n16th s fenghui rd; xi'an, shaanxi ; CH
• MDR Report Key: 18421016
• MDR Text Key: 331666786
• Report Number: 3016774562-2023-02510
• Device Sequence Number: 1
• Product Code: IRT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: NA-H21B
• Device Lot Number: 210101
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2023
• Distributor Facility Aware Date: 12/08/2023
• Device Age: 2 YR
• Date Report to Manufacturer: 12/13/2023
• Patient Sequence Number: 1
• Patient Sex: Female