MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-30 for CONAIR WW52Y manufactured by Conair Corporation.
[125612608]
On 10/30/2018 - the consumer will be receiving a replacement, therefore the manufacturer will not be receiving the device for an investigation.
Patient Sequence No: 1, Text Type: N, H10
[125612629]
On (b)(4) 2018 - per the consumer, the product shattered. The consumer is going to provide the serial number for a replacement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222304-2018-00023 |
| MDR Report Key | 8019065 |
| Date Received | 2018-10-30 |
| Date of Report | 2018-10-01 |
| Date of Event | 2018-09-24 |
| Date Added to Maude | 2018-10-30 |
| 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 | 0 |
| Brand Name | CONAIR |
| Generic Name | BMI SCALE |
| Product Code | MNW |
| Date Received | 2018-10-30 |
| Model Number | WW52Y |
| Device Availability | N |
| 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 | 2018-10-30 |