• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN ALEVE DIRECT THERAPY STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER Back to Search Results
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
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.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameALEVE DIRECT THERAPY
Type of DeviceSTIMULATOR, 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 Key6955911
MDR Text Key252255483
Report Number2183164-2017-05003
Device Sequence Number1
Product Code NUH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPC90023
Device Catalogue NumberPC90023
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

-
-