MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; HEATING PAD

Model Number HP01RB

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 06/09/2017

Event Type  Injury  

Manufacturer Narrative

On 7/20/2017, we have requested the device be returned to the manufacturer.To date, we have not received the device.

Event Description

On 7/19/2017, the consumer claims her daughter received severe burns on her legs.The daughter was laying down with the product on her.

Manufacturer Narrative

On (b)(6) 2017 - we have requested the device be returned to the manufacturer.To date, we have not received the device.Manufacturers narrative: testing was not possible as returned product was not working on receipt.Visual inspection was done and a summary was provided below.Visual inspection: without a full understanding or analysis of the use site, there are a number of conditions that are obvious from the returned sample and the complaint.A copy of the ib is included and the points discussed highlighted.1 - the heating pad was used in a folded condition.We state is the instruction booklet (ib) that the heating pad is to be "draped" over the part of the body to be treated.The heating pad is not to be folded.A) when the heating pad is folded, the internal wires can cross and are then not controlled by the thermostat.The area that the wire cross can get excessively hot when used for long periods of time.B) this is why we recommend a 20 min use time and to check frequently under pad for overheat indications.2 - unit was used under covers.If she was laying in bed, with the pad on top of her legs and the sheets and her legs got burned, it would imply the heating pad was between her legs and the comforter (and sheets).Using the heating pad under covers increases the chance of hot spots when using it in a folded condition.

Event Description

On (b)(6) 2017 - the consumer claims her daughter received a severe burns on her legs.The daughter was laying down with the product on her.

• Brand Name: CONAIR
• Type of Device: HEATING PAD
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford CT 06902
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06902
• MDR Report Key: 6727568
• MDR Text Key: 80516418
• Report Number: 1222304-2017-00026
• Device Sequence Number: 1
• Product Code: IRT
• UDI-Device Identifier: 74108104670
• UDI-Public: 74108104670
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: HP01RB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 35 YR