MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for CONAIR CORPORATION WW910F manufactured by Conair Corporation.
[144169735]
On (b)(6) 2019 - the consumer has requested a replacement device and will not send the device to the manufacturer. Therefore an investigation will not take place.
Patient Sequence No: 1, Text Type: N, H10
[144169736]
On (b)(6) 2019 - the consumer claims that the glass on the product has shattered. The consumer has accepted a replacement.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1222304-2019-00012 |
MDR Report Key | 8577703 |
Date Received | 2019-05-03 |
Date of Report | 2019-04-08 |
Date of Event | 2019-04-05 |
Date Added to Maude | 2019-05-03 |
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 CORPORATION |
Generic Name | BMI SCALE |
Product Code | MNW |
Date Received | 2019-05-03 |
Model Number | WW910F |
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 | 2019-05-03 |