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

Model Number WW721XF

Device Problems Fail-Safe Problem (2936); Appropriate Term/Code Not Available (3191)

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

Event Date 11/04/2022

Event Type  malfunction  

Manufacturer Narrative

On 12/1/2022 - the consumer accepted a replacement product and will not return the product to the manufacturer for an investigation.Therefore an investigation will not occur.

Event Description

On (b)(6) 2022: the consumer claims the product shattered.Injuries did not occur and the consumer accepted replacement.

Event Description

11/7/2022 the consumer cliams the product shattered.Injuries did not occur and the consumer accepted replacement.

Manufacturer Narrative

12/1/2022 - the consumer accepted a replacement product and will not return the product to the manufacturer for an investigation.Therefore an investigation will not occur.7/8/2023 - submitting a supplemental emdr to the fda as we mistakenly entering the incorrect medical device problem code.Changing the medical device problem code "fail-safe problem to "appropriate term / code not available.

• 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 ; 2033519458
• MDR Report Key: 15893914
• MDR Text Key: 307892603
• Report Number: 1222304-2022-00036
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108333025
• UDI-Public: 74108333025
• 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: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: WW721XF
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1