MAUDE Adverse Event Report: COVIDIEN ALEVE DIRECT THERAPY; STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER

Model Number PC90023

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2017

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.

Event Description

According to the reporter, during use, the device got hot and was smoking on one side of unit and charred the black corrugated pad and the gel pad.The patient was alive with no injury.

Manufacturer Narrative

Submit date: 10/31/2017 this initial 3500a was inadvertently reported in error as covidien does not own the 510k for the reported item.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ALEVE DIRECT THERAPY
• Type of Device: STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
• Manufacturer (Section D): COVIDIEN; 1313 w grant blvd; wabasha MN 55981
• Manufacturer (Section G): COVIDIEN; 1313 w grant blvd; wabasha MN 55981
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6955911
• MDR Text Key: 90772358
• Report Number: 2183164-2017-05003
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PC90023
• Device Catalogue Number: PC90023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1