MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-10-17 for CONAIR WW78 manufactured by Conair Corporation.
[57585669]
On 10/17/2016 - we have requested the device be returned to the manufacturer. To date, we have not received the device.
Patient Sequence No: 1, Text Type: N, H10
[57585670]
On 10/17/2016 - the consumers granddaughter allegedly dropped a bottle on the product which cause the glass to shatter. The consumers granddaughter received cuts on leg. No medical attention was required.
Patient Sequence No: 1, Text Type: D, B5
[66233377]
On 10/17/2016, we have requested the device be returned to the manufacturer. To date, we have not received the device. On (b)(6) 2017 added the upc code to the supplemental emdr. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[66233378]
On (b)(6) 2016, the consumers granddaughter allegedly dropped a bottle on the product which cause the glass to shatter. The consumers granddaughter received cuts on leg. No medical attention was required.
Patient Sequence No: 1, Text Type: D, B5
[67462495]
On 10/17/2016 - we have requested the device be returned to the manufacturer. To date, we have not received the device. On 1/31/2017 - added the upc code to the supplemental emdr. On 2/15/2017 - manufacturers narrative: the product was received in the condition that deems impossible to perform testing due to the shattered glass. This occurence rarely happens with this product.
Patient Sequence No: 1, Text Type: N, H10
[67462496]
(b)(6) 2016 - the consumer's grand daughter allegedly dropped a bottle on the product which cause the glass to shatter. The consumer's grand daughter received cuts on leg. No medical attention was required.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1222304-2016-00041 |
MDR Report Key | 6033147 |
Report Source | CONSUMER |
Date Received | 2016-10-17 |
Date of Report | 2016-09-19 |
Date of Event | 2016-09-17 |
Date Added to Maude | 2016-10-17 |
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 | 2016-10-17 |
Model Number | WW78 |
Device Availability | * |
Device Age | DA |
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 | 2016-10-17 |