MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-08-15 for CONAIR WW707 manufactured by Conair Corporation.
[52109831]
Our risk management team has discussed the issue with the consumer. Consumer will not be sent a replacement. Device not returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[52109832]
On 8/8/2016 - the consumer alleges that the product was damaged. The consumer received a cut on a finger while attempting to fix the product.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1222304-2016-00035 |
MDR Report Key | 5876402 |
Report Source | CONSUMER |
Date Received | 2016-08-15 |
Date of Report | 2016-05-05 |
Date of Event | 2016-05-05 |
Date Added to Maude | 2016-08-15 |
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 | 2016-08-15 |
Model Number | WW707 |
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 CT 06902 US 06902 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2016-08-15 |