MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; PARRAFIN BATH

Model Number SSPB10F

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

(b)(6) 2018 - the consumer claims the product scalded her feet and noticed the water temp was 140 degrees.Medical attention was not received.

• Brand Name: CONAIR
• Type of Device: PARRAFIN BATH
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford 06902
• Manufacturer Contact: 1 cummings point rd.; stamford,
• MDR Report Key: 7800836
• MDR Text Key: 117718581
• Report Number: 1222304-2018-00017
• Device Sequence Number: 1
• Product Code: IMC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SSPB10F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Date Manufacturer Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR