MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR CORPORATION; HEATING PAD

Model Number HP01RB

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

Patient Problem Burn, Thermal (2530)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6) 2019 we have requested the device be returned to the manufacturer.To date, we have not received the device.

Event Description

(b)(6) 2019 the consumer claims to have received a burn on her shoulder while in use of the product.

• Brand Name: CONAIR CORPORATION
• Type of Device: HEATING PAD
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford 06902
• Manufacturer Contact: 1 cummings point rd.; stamford,
• MDR Report Key: 9510695
• MDR Text Key: 173318477
• Report Number: 1222304-2019-00031
• Device Sequence Number: 1
• Product Code: IRT
• UDI-Device Identifier: 74108104649
• UDI-Public: 74108104649
• 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: 12/03/2019

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: No
• 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: 50 YR