MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; HEATING PAD

Model Number HP15

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Injury (2348)

Event Date 12/08/2017

Event Type  Injury  

Manufacturer Narrative

On 3/28/2017 - we have requested the device be returned to the manufacturer.To date we have not received the device.Device not returned to manufacturer.

Event Description

On (b)(6) 2017 - the consumer claims to have received a burn while in use of the product.Once the burn was received, the consumer jumped and strained her back and hip.Medical attention was received for the hip and back.

Manufacturer Narrative

On (b)(6) 2017 - we have requested the device be returned to the manufacturer.To date we have not received the device.On (b)(6) 2017 - manufacturers narrative: on inspection of returned sample, the following is noted.Sample was returned in a non-working condition on (b)(5) 2017.Pad had a noticeable burn hole through both sides of the pvc.Line cord was severed at the strain relief indicating abuse line cord was partially severed.In the ib, we state the unit should be inspected prior to use, making sure there is no damage prior to being used.Line cord is to be checked there has to be consumer abuse to partially sever the line cord.This would require strain and force abuse on the line cord.Once the line cord was partially severed, the disconnected line caused the thermostat to be bypassed and the temperature loop to see higher wattage then designed.This caused the over heat condition.

Event Description

On (b)(6) n2017 - the consumer claims to have received a burn while in use of the product.Once the burn was received, the consumer jumped and strained her back and hip.Medical attention was received for the hip and back.

• 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
• MDR Report Key: 6439537
• MDR Text Key: 71034116
• Report Number: 1222304-2017-00015
• 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: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: HP15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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): Other
• Patient Age: 67 YR