MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; BMI SCALE

Model Number WW912F

Device Problem Break (1069)

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

Event Date 04/01/2020

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2020 - the consumer accepted a replacement and returned the product.An investigation will not take place.

Event Description

On (b)(6) 2020 - per consumer, the glass on the product was breaking off.The consumer accepted a replacement.

Manufacturer Narrative

09/24/2020 - the late submission was due to an oversight and we will be taking the necessary action to follow-up with the consumer.09/25/2020 - we received additional details from our call center that originally received the complaint.The consumer has accepted a replacement product.Therefore an investigation will not occur.Below is the statement from our call center: call center's statement.(b)(6) 2020 date of injury.Did not call until 04/01/20.Customer stated it was not bad or a major cut, just a little cut on her toe and only mentioned it, almost dismissive, half way thru the call.Did not need medical attention.Called back on (b)(6) because she was expecting a replacement and also sounded like that was the customers expectation on the original call.We had looked on wednesday and did not find the claim submission form even though on the original call the rep went thru the steps for filling a claim.

Event Description

09/23/2020 - the consumer claims the glass has shattered on the product.The consumer stepped on the glass and cut her foot.

• Brand Name: CONAIR
• Type of Device: BMI SCALE
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings poit rd.; stamford 06902
• MDR Report Key: 10573262
• MDR Text Key: 209806405
• Report Number: 1222304-2020-00016
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108376930
• UDI-Public: 74108376930
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WW912F
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR