MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-08-21 for CONAIR SSPB10F manufactured by Conair Corporation.
[117718581]
(b)(6) 2018 - the consumer has returned the device to the manufacturer. An evaluation is currently in progress. 8/20/2018 - below is the manufacturers narrative: conclusion: consumer claims the unit scalded her feet and noticed the "water" temp was over 140 degrees. Assume she meant "wax" temp. Consumer claims the unit scalded her feet and noticed the "water" temp was over 140 degrees. Assume she meant "wax" temp. Added wax melted at 2'20". Only minimal wax remains at the bottom. Unit is ready to use. Temperature of wax is 39 c (102 f). Maximum (equilibrium) recorded temperature for the wax was 60 c (140f) at 3'30". Equilibrium is defined as 3 consecutive readings 5 min apart that did not change. Note: in the safety agency testing (ul) report equilibrium temperature was 65. 4 c (150 f) for wax and is considered acceptable. Max allowable temperature for wax is 70 c (158 f). Ib warnings and cautions were not followed.
Patient Sequence No: 1, Text Type: N, H10
[117718582]
(b)(6) 2018 - the consumer claims the product scalded her feet and noticed the water temp was 140 degrees. Medical attention was not received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222304-2018-00017 |
| MDR Report Key | 7800836 |
| Report Source | CONSUMER |
| Date Received | 2018-08-21 |
| Date of Report | 2018-04-19 |
| Date of Event | 2018-02-01 |
| Date Mfgr Received | 2018-07-27 |
| Date Added to Maude | 2018-08-21 |
| 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 | PARRAFIN BATH |
| Product Code | IMC |
| Date Received | 2018-08-21 |
| Returned To Mfg | 2018-07-27 |
| Model Number | SSPB10F |
| 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 | 2018-08-21 |