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

Model Number WW390F

Device Problem Burst Container or Vessel (1074)

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

Event Date 08/02/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 2022 - the consumer accepted a replacement and discarded the original product.Therefore an investigation will not occur.

Event Description

(b)(6) 2022 - the consumer claims the product exploded.Injuries did not occur.The consumer discarded the product and 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: 15182230
• MDR Text Key: 305075491
• Report Number: 1222304-2022-00032
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108371942
• UDI-Public: 74108371942
• 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: 08/08/2022

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: WW390F
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other