MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-10-17 for CONAIR WW701Y manufactured by Conair Corporation.
[57625847]
On (b)(6) 2016 the device will not be returned for evaluation as the consumer has agreed to received a new product. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[57625848]
On (b)(6) 2016 the consumer alleges that the glass on the product has shattered. No injuries have occurred. The consumer has agreed to accept another product.
Patient Sequence No: 1, Text Type: D, B5
[67176460]
On 10/12/2016 - the device will not be returned for evaluation as the consumer has agreed to received a new product. On 2/7/2016 - supplemental emdr contains the udi.
Patient Sequence No: 1, Text Type: N, H10
[67176461]
On 10/12/2016 - the consumer alleges that the glass on the product has shattered. No injuries have occurred. The consumer has agreed to accept another product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222304-2016-00040 |
| MDR Report Key | 6033143 |
| Report Source | CONSUMER |
| Date Received | 2016-10-17 |
| Date of Report | 2016-10-03 |
| Date of Event | 2016-09-23 |
| Date Added to Maude | 2016-10-17 |
| 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 | 2016-10-17 |
| Model Number | WW701Y |
| 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 | 2016-10-17 |