MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR CORPORATION; MASSAGER

Model Number BM1RLF

Device Problems Break (1069); Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2019

Event Type  malfunction  

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 that he plugged in the unit, the remote bubbled up and circuit breakers broke.The outlet melted.Injuries did not occur.

• Brand Name: CONAIR CORPORATION
• Type of Device: MASSAGER
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford 06902
• Manufacturer Contact: 1 cummings point rd.; stamford,
• MDR Report Key: 9510696
• MDR Text Key: 194140186
• Report Number: 1222304-2019-00032
• Device Sequence Number: 1
• Product Code: MNW
• UDI-Device Identifier: 74108061072
• UDI-Public: 74108061072
• 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: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BM1RLF
• 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 the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR