MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-07-16 for CONAIR WW707Y manufactured by Conair Corporation.
[114432724]
(b)(6) 2018 - the consumer accepted a replacement of the product and will not return the product for investigation. Therefore, an investigation will not occur.
Patient Sequence No: 1, Text Type: N, H10
[114432725]
(b)(6) 2018 - the consumer claims that the product is in pieces. The consumer accepted a refund.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222304-2018-00014 |
| MDR Report Key | 7690527 |
| Report Source | CONSUMER |
| Date Received | 2018-07-16 |
| Date of Report | 2018-07-16 |
| Date of Event | 2018-06-25 |
| Date Added to Maude | 2018-07-16 |
| 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, |
| 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 | 2018-07-16 |
| Model Number | WW707Y |
| 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 06902 US 06902 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-16 |