MAUDE Adverse Event Report: CONAIR CORPORATION BMI SCALE

Model Number WW78

Device Problem Device Slipped (1584)

Patient Problem Tissue Damage (2104)

Event Date 03/11/2016

Event Type  Injury  

Manufacturer Narrative

On 5/4/2016 - we have not received the product to date.We have requested the mailing address from the consumer on 4/4/2016.The consumer has not provided the mailing address.

Event Description

On 5/4/2016 - the consumer alleges that the product became loose and cut the sole on the consumers foot.Medical attention was received.

• Brand Name: BMI SCALE
• Type of Device: SCALE
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford CT 06902
• Manufacturer Contact: 1 cummings point rd.; stamford 06902
• MDR Report Key: 5630932
• MDR Text Key: 44389002
• Report Number: 1222304-2016-00026
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: WW78
• 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): Hospitalization
• Patient Age: 55 YR