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

Model Number WW711

Device Problem Fire (1245)

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

Event Date 01/10/2022

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2022 - we have requested the device be returned to the manufacturer for an investigation.To date, we have not received the device.

Event Description

On (b)(6) 2022 - the consumer claims the device caught on fire while being placed on the consumers coffee table.As a result the consumer house was full of smoke.Injuries did not occur and the consumer is filing a claim for smoke damage.

Manufacturer Narrative

01/25/2022 - we have requested the device be returned to the manufacturer for an investigation.To date, we have not recieved the device.06/02/2022 - the device was returned to the manufacturer and was evaluated.Below is the manufacturers narrative: manufacturers narrative: model returned was ina non-working condition.Received 3/2/22.Unit could not be tested.The scale uses 3v coin cell batteries.The only power source or potential source of fire.As the battery area was not effected by the fire, the source could not be the scale.Packaging also indicates the fire was "outside" the unit as no internal burns are observed.The main burn marks are located on the edge of the packaging.Along this axis there is no ability for fire from our 3v energy source, these burns are located on the exterior perimeter of the box.

Event Description

(b)(6) 2022 - the consumer claims the device caught on fire while being placed on the consumers coffee table.As a result the consumer house was full of smoke.Injuries did not occur and the consumer is filiing a claim for smoke damage.

• 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 06614
• MDR Report Key: 13342548
• MDR Text Key: 286599540
• Report Number: 1222304-2022-00002
• 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
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: WW711
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other