MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; HEATING PAD

Model Number HP15RB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 02/13/2020

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2020: the consumer has provided the device to the manufacturer.An investigation is currently underway.

Event Description

On (b)(6) 2020 - the consumer claims to have burned her buttocks while in use of the product.

Event Description

2/14/2020 - the consumer claims to have burned her buttocks while in use of the product.

Manufacturer Narrative

3/9/2020 - the consumer has provided the device to the manufacturer.An investigation is currently underway.6/25/2021 - the investigation report is complete.Below is the manufacturers narrative: manufacturers narrative: visual review indicated the pad had creases melted into the cover.Creases are caused by using the bad is a "scrunched" or near folded condition.See attached photos.For the crease to take a set, it had to be used folded or scrunched while heated.The burn marks or holes in the pictures were located "on" or "near" the creases in the pvc enclosure.The pvc should remain wrinkle free.It is surmised the creasing caused the internal heating wire to move.Per the attached ib, you are to follow the following directions to avoid over heating: 1 - use in a flat condition, on top of the body part being treated.2 - do not use any covers on top of the heating pad during use.3 - check heating pad freuntly during use.4 - do not sit or lay on top of the heating pad during use.

Event Description

On (b)(6) 2020 - the consumer claims to have burned her buttocks while in use of the product.

Manufacturer Narrative

On 3/9/2020 - the consumer has provided the device to the manufacturer.An investigation is currently underway.On 6/25/2021 - the investigation report is complete.Below is the manufacturers narrative: manufacturers narrative: visual review indicated the pad had creases melted into the cover.Creases are caused by using the bad is a "scrunched" or near folded condition.For the crease to take a set, it had to be used folded or scrunched while heated.The burn marks or holes in the pictures were located "on" or "near" the creases in the pvc enclosure.The pvc should remain wrinkle free.It is surmised the creasing caused the internal heating wire to move.Per the attached ib, you are to follow the following directions to avoid over heating: 1 - use in a flat condition, on top of the body part being treated.2 - do not use any covers on top of the heating pad during use.3 - check heating pad freuntly during use.4 - do not sit or lay on top of the heating pad during use.On 7/7/2021 - resubmitting emdr as i made an error with the consumers first name.The consumers first name should be (b)(6).

• Brand Name: CONAIR
• Type of Device: HEATING PAD
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd.; stamford CT 06902
• MDR Report Key: 9848132
• MDR Text Key: 196391584
• Report Number: 1222304-2020-00003
• Device Sequence Number: 1
• Product Code: IRT
• UDI-Device Identifier: 74108104670
• UDI-Public: 74108104670
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2020

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: HP15RB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2020
• Supplement Dates Manufacturer Received: 02/25/2020; 02/25/2020
• Supplement Dates FDA Received: 07/07/2021; 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR