MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-01-25 for CONAIR WW52Y manufactured by Conair Corporation.
[134086516]
On 1/25/2018 - we have received the device on 1/23/2018 and the manufacturers inspection was complete. Below is the manufacturers narrative; manufacturers narrative during the process to make the glass shard proof, or safety glass, there is an anomaly that is seen on very few finished glass parts. There is internal stress that is sometimes created during the heat process. This stress can not be determined through normal testing. During use at specific temperatures the stress becomes apparent though making contact by either stepping or banging the scale against something hard. Sometimes the internal stress breaks the glass when no external event caused it. The number of events is very low and the technology so far has not provided a solution to prevent this on all glass scales.
Patient Sequence No: 1, Text Type: N, H10
[134086517]
On (b)(6) 2018 - the consumer claims that the product shattered. While cleaning the consumer cut his finger. Medical attention was not received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222304-2019-00001 |
| MDR Report Key | 8277199 |
| Report Source | CONSUMER |
| Date Received | 2019-01-25 |
| Date of Report | 2018-01-03 |
| Date of Event | 2018-12-23 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2019-01-25 |
| 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 | 3 |
| Brand Name | CONAIR |
| Generic Name | BIA SCALE |
| Product Code | MNW |
| Date Received | 2019-01-25 |
| Returned To Mfg | 2019-01-21 |
| Model Number | WW52Y |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-01-25 |