MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-29 for BMI SCALE WW400GD manufactured by Conair Corporation.
[41656740]
On (b)(6) 2016 - the consumer has agreed to accept a replacement device rather mailing the device for manufacturers investigation. Therefore, an investigation for the product is not necessary. The replacement device was sent to the consumer on march 21st, 2016. Consumer request replacement product.
Patient Sequence No: 1, Text Type: N, H10
[41656741]
On (b)(6) 2016: the consumer alleged that the glass shattered on the product while standing on it. The consumer was not injured during the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222304-2016-00019 |
| MDR Report Key | 5531492 |
| Date Received | 2016-03-29 |
| Date of Report | 2016-03-18 |
| Date of Event | 2016-03-18 |
| Date Added to Maude | 2016-03-29 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 1 CUMMINGS POINT RD. |
| Manufacturer City | STAMFORD CT |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BMI SCALE |
| Generic Name | WEIGHT WATCHERS BMI SCALE |
| Product Code | MNW |
| Date Received | 2016-03-29 |
| Model Number | WW400GD |
| Device Availability | * |
| 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 | 2016-03-29 |