MAUDE Adverse Event Report: SUNBEAM PRODUCTS, INC. HEALTH O METER; BODY FAT SCALE

Model Number BFM081DQ2-63-U

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Event Description

Consumer alleges his scale broke and he received a cut on the bottom of his right foot.There was not a report of property damage(s) with this incident.

Manufacturer Narrative

Consumer discarded product.

• Brand Name: HEALTH O METER
• Type of Device: BODY FAT SCALE
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC.; 6655 peachtree dunwoody rd.; atlanta GA 30328
• Manufacturer (Section G): SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO.,LTD; block 48, changxing industrial; changzhen gongming town guangm; shenzhen, guangdong 51813 2; CH 518132
• Manufacturer Contact: michael miles ; 303 nelson ave.; neosho, mo 64850 ; CH 64850
• MDR Report Key: 18668277
• MDR Text Key: 334904351
• Report Number: 3006624940-2024-00013
• Device Sequence Number: 1
• Product Code: MNW
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/08/2024

1 Device was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BFM081DQ2-63-U
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown