MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-27 for CONAIR WW37GD manufactured by Conair Corporation.
[112718912]
On (b)(6) 2018 - the device was not returned to the manufacturer. Therefore, a investigation cannot be completed.
Patient Sequence No: 1, Text Type: N, H10
[112718913]
On (b)(6) 2018 - per the consumer, the product shattered into glass shards. The consumer was not injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222304-2018-00011 |
| MDR Report Key | 7641601 |
| Date Received | 2018-06-27 |
| Date of Report | 2018-06-27 |
| Date of Event | 2018-04-09 |
| Date Added to Maude | 2018-06-27 |
| 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 | 2018-06-27 |
| Model Number | WW37GD |
| 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 | 1. Other | 2018-06-27 |