MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; BMI SCALE

Model Number UNKNOWN

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

On 11/12/2020 - we have requeted the device be returned to the manufacturer for an investigation.To date, we have not recieved the device.

Event Description

On 11/10/2020 - the consumer alleges that the product shattered in the bathroom.The consumer had a laceration as a result.

Manufacturer Narrative

11/12/2020: we have requested the device be returned to the manufacturer for an investigation.To date, we have not received the device.4/27/2021: per the fda's request, submitted a supplemental mdr that does not include the age and dob.I also noticed the common device name and product code was incorrect.I made the change from a heating pad (irt) to a bmi scale (mnw).

Event Description

On (b)(6) 2020: the consumer alleges that the product shattered in the bathroom.The consumer had a laceration as a result.4/27/2021: per the fda's request, submitted a supplemental mdr that does not include the age and dob.

• Brand Name: CONAIR
• Type of Device: BMI SCALE
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd.; stamford CT 06902
• MDR Report Key: 10828770
• MDR Text Key: 215922824
• Report Number: 1222304-2020-00024
• Device Sequence Number: 1
• Product Code: MNW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR