MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-17 for CONAIR CORPORATION WW78 manufactured by Conair Corporation.
[145639547]
On (b)(6) 2019 - we have received the device on (b)(6) 2019. The investigation has been complete. Below is the manufacturers narrative: manufacturers narrative: testing was not required. Performance was not an issue. Rolled steel has internal stresses that make it difficult to attach. Extra processes are in place, flattening of the steel, heat treating and a strong glue is used. With these steps in place, almost 100% of problems are eliminated. We have not seen this problem before and will be sure to advise production to be aware and check during the inspections.
Patient Sequence No: 1, Text Type: N, H10
[145639548]
On (b)(6) 2019 - the consumer claims the metal strips on the product popped up and cut his sons finger. Medical attention was not received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222304-2019-00013 |
| MDR Report Key | 8621061 |
| Date Received | 2019-05-17 |
| Date of Report | 2019-05-22 |
| Date of Event | 2019-03-10 |
| Date Mfgr Received | 2019-05-15 |
| Device Manufacturer Date | 2011-03-01 |
| Date Added to Maude | 2019-05-17 |
| 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, |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CONAIR CORPORATION |
| Generic Name | BIA SCALE |
| Product Code | MNW |
| Date Received | 2019-05-17 |
| Returned To Mfg | 2019-05-15 |
| Model Number | WW78 |
| 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 | 2019-05-17 |