MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-09 for CONAIR WW-400 manufactured by Conair Corporation.
[64553482]
On 1/4/2017 - we have requested the device be returned to the manufacturer. To date, we have not received the device.
Patient Sequence No: 1, Text Type: N, H10
[64553483]
On 1/3/2017 - the consumer claims to have stood on the product. The glass on the product has shattered. No injuries occured
Patient Sequence No: 1, Text Type: D, B5
[68492328]
On 1/4/2016 we have requested the device be returned to the manufacturer. To date, we have not received the device. On 2/15/2016 - manufacturers narrative: the product was received in a condition that deems impossible to perform testing due to the shattered glass. This occurence rarely happens with this product.
Patient Sequence No: 1, Text Type: N, H10
[68492329]
On (b)(6) 2017 - the consumer claims to have stood on the product. The glass on the product has shattered. No injuries occured
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222304-2017-00001 |
| MDR Report Key | 6232461 |
| Date Received | 2017-01-09 |
| Date of Report | 2016-12-12 |
| Date of Event | 2016-11-25 |
| Date Added to Maude | 2017-01-09 |
| 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 06902 |
| Manufacturer Country | US |
| Manufacturer Postal | 06902 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONAIR |
| Generic Name | BMI SCALE |
| Product Code | MNW |
| Date Received | 2017-01-09 |
| Model Number | WW-400 |
| Device Availability | * |
| 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 | 2017-01-09 |