MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; MASSAGER

Model Number SPS1K

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2020 - we have requested the devised be returned to the manufacturer for an investigation.To date we have not received the device.

Event Description

On (b)(6) 2020 the consumer alleged while sleeping with the product, the product burned a dime sized hole in another pillow.

Manufacturer Narrative

10/28/2020, we have received the device and the investigation was complete.Below is the manufacturers conclusions.Model was returned and in a non-working condition.Batteries had leaked acid and developed a short that caused the incident.The batteries were not removed or replaced prior to them leaking acid.The acid caused the batteries to short and created heat due to the battery power.The excessive heat from the batteries caused the battery box to melt and caused the burn marks indicated by the consumer.

Event Description

On (b)(6) 2020, the consumer alleged while sleeping with the product, the product burned a dime sized hole in another pillow.

• Brand Name: CONAIR
• Type of Device: MASSAGER
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings poit rd.; stamford 06902
• MDR Report Key: 10455455
• MDR Text Key: 205555815
• Report Number: 1222304-2020-00014
• Device Sequence Number: 1
• Product Code: ISA
• UDI-Device Identifier: 74108314826
• UDI-Public: 74108314826
• 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
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: SPS1K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 MO