MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-10-31 for CONAIR HM40F manufactured by Conair Corporation.
[90651074]
On (b)(6) 2017 - we have requested the device be returned to the manufacturer. To date, the device has not been returned.
Patient Sequence No: 1, Text Type: N, H10
[90651075]
On (b)(6) 2017 - per the consumers attorney, the consumer burnt their hand while in use of the product. The consumer is currently going through treatment.
Patient Sequence No: 1, Text Type: D, B5
[95207304]
(b)(4) 2017 - we have requested the device be returned to the manufacturer. To date, the device has not been returned. On 12/15/2017 - manufacturers narrative: this product was temperature and performance tested in the lab using calibrated ul test equipment while being operated according to the instruction booklet. The product performed properly and within the allowable temperature specs (see attached test record sheet and ib with highlighted warnings relating to possible burns if not properly operated). The product was also tested by placing my own hand in the unit in accordance with the ib and let run until water reservoir was completely empty (approx 20+ minutes). No burns were experienced while using it or the following day. The product was found to be operating properly when it was tested in the lab using calibrated ul test equipment and with actual hands. There are warnings in the ib that instruct the user how to use the product and how to avoid burns. The user apparently did not use the product properly or according to the ib and / or taken the necessary precautions to prevent burns.
Patient Sequence No: 1, Text Type: N, H10
[95207305]
(b)(6) 2017 - per the consumers attorney, the consumer burnt their hand while in use of the product. The consumer is currently going through treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222304-2017-00032 |
| MDR Report Key | 6989956 |
| Report Source | CONSUMER |
| Date Received | 2017-10-31 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-07-24 |
| Date Added to Maude | 2017-10-31 |
| 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 | HAND MASSAGER |
| Product Code | ISA |
| Date Received | 2017-10-31 |
| Model Number | HM40F |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2017-10-31 |