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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR CORPORATION BIA SCALE

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CONAIR CORPORATION CONAIR CORPORATION BIA SCALE Back to Search Results
Model Number WW78
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Injury (2348)
Event Date 03/10/2019
Event Type  malfunction  
Manufacturer Narrative
On (b)(6) 2019 - we have received the device on (b)(6) 2019. The investigation has been complete. Below is the manufacturers narrative: manufacturers narrative: testing was not required. Performance was not an issue. Rolled steel has internal stresses that make it difficult to attach. Extra processes are in place, flattening of the steel, heat treating and a strong glue is used. With these steps in place, almost 100% of problems are eliminated. We have not seen this problem before and will be sure to advise production to be aware and check during the inspections.
 
Event Description
On (b)(6) 2019 - the consumer claims the metal strips on the product popped up and cut his sons finger. Medical attention was not received.
 
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Brand NameCONAIR CORPORATION
Type of DeviceBIA SCALE
Manufacturer (Section D)
CONAIR CORPORATION
1 cummings point rd
stamford 06902
Manufacturer Contact
1 cummings point rd.
stamford, 
MDR Report Key8621061
MDR Text Key145639547
Report Number1222304-2019-00013
Device Sequence Number1
Product Code MNW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 05/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberWW78
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/17/2019 Patient Sequence Number: 1
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