MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; BMI SCALES

Model Number WW711XF

Device Problem Break (1069)

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

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 2020 the consumer accepted a replacement and will not be providing the defective product to the manufacturer.Therefore an investigation will not occur.

Event Description

(b)(6) 2020 the consumer claims the product shattered.Injuries did not occur.The consumer accepted another model of the same product.

• Brand Name: CONAIR
• Type of Device: BMI SCALES
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings poit rd.; stamford 06902
• Manufacturer Contact: 1 cummings point rd.; stamford 06902
• MDR Report Key: 10929486
• MDR Text Key: 219961313
• Report Number: 1222304-2020-00029
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108411976
• UDI-Public: 74108411976
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: WW711XF
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR