MAUDE Adverse Event Report: CONAIR LLC. CONAIR; BMI SCALE

Model Number WW711XF

Device Problem Break (1069)

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

Event Date 03/28/2022

Event Type  malfunction  

Manufacturer Narrative

05042022 - the consumer accepted a replacement product.Therefore the device will not be returned to the manufacturer for an investigation.

Event Description

3/28/2022 - the consumer claims the product spontainiouly combusted.Injuries did not occur and the consumer accepted a replacement.

• Brand Name: CONAIR
• Type of Device: BMI SCALE
• Manufacturer (Section D): CONAIR LLC.; 1 cummings point rd.; stamford CT 06902
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06902
• MDR Report Key: 14285861
• MDR Text Key: 299583529
• Report Number: 1222304-2022-00011
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108337290
• UDI-Public: 74108337290
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: WW711XF
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other