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

MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE DEFIB/PACING ELECTRODE

  • 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
 

BIO-DETEK INCORPORATED PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE DEFIB/PACING ELECTRODE Back to Search Results
Model Number 8900-4006
Device Problem Sparking (2595)
Patient Problem Burn(s) (1757)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
 
Event Description
Complainant alleged that while cardioverting an (b)(6)-year-old male patient, the electrode pads sparked. Complainant indicated that the patient received a first degree burn and burn cream was applied to the area.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE
Type of DeviceDEFIB/PACING ELECTRODE
Manufacturer (Section D)
BIO-DETEK INCORPORATED
525 narragansett park drive
pawtucket RI 02861
Manufacturer Contact
525 narragansett park drive
pawtucket, RI 02861
4017291400
MDR Report Key8629231
MDR Text Key145683493
Report Number1218058-2019-00045
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/26/2020
Device Model Number8900-4006
Device Catalogue Number8900-4006
Device Lot Number0919
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/26/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-