MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-02-19 for CONAIR SCALE WW401GD manufactured by Conair Corporation.
[38586472]
On 2/9/2016 - the products has been returned for evaluation. Evaluation is currently in progress.
Patient Sequence No: 1, Text Type: N, H10
[38586473]
On (b)(6) 2016 - the consumer alleges that the product exploded and cut the consumers finger.
Patient Sequence No: 1, Text Type: D, B5
[40350876]
Feb. 09, 2016 - the product has been returned for evaluation. Evaluation is currently in progress. Mar. 07, 2016 - the product received is in the condition that deems impossible to perform testing due to the shattered glass. This occurence rarely happens with this product. Device is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[40350877]
On (b)(6) 2016 - the consumer alleges that the product exploded and cut the consumers finger.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1222304-2016-00009 |
MDR Report Key | 5447734 |
Report Source | CONSUMER |
Date Received | 2016-02-19 |
Date of Report | 2016-01-21 |
Date of Event | 2016-01-21 |
Date Added to Maude | 2016-02-19 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 0 |
Initial Report to FDA | 0 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Street | 1 CUMMINGS POINT RD. |
Manufacturer City | STAMFORD CT 06902 |
Manufacturer Country | US |
Manufacturer Postal | 06902 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CONAIR SCALE |
Generic Name | BMI SCALE - WW41GD |
Product Code | MNW |
Date Received | 2016-02-19 |
Returned To Mfg | 2016-02-09 |
Model Number | WW401GD |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | CONAIR CORPORATION |
Manufacturer Address | 1 CUMMINGS POINT RD STAMFORD CT 06902 US 06902 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2016-02-19 |