FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

EMPI EMPI DUPEL IONTOPHORESIS SYSTEM   back to search results
Model Number DUPEL
Patient Outcome  Required Intervention;
Event Description

Pt received iontophoresis treatment in pt. Treatment area under electrodes was reddened at the end of treatment. Pt returned for treatment 3 days later and reported that they had a burn in the area that was reddened (proximal to rt lateral epicondyle. 75 cm x. 75 cm). Area appeared dark and blister-like. Pt saw physician on the next day. Treatment was discontinued until the wound was healed.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameEMPI
Type of DeviceDUPEL IONTOPHORESIS SYSTEM
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
EMPI
599 cardigan rd
st paul MN 55126
Device Event Key384220
MDR Report Key395211
Event Key373379
Report NumberMW1025071
Device Sequence Number1
Product CodeEGJ
Report Source Voluntary
Report Date 05/07/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/16/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberDUPEL
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/06/2002
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Patient TREATMENT DATA
Date Received: 05/16/2002 Patient Sequence Number: 1
#TreatmentTreatment Date
1 THERAPY SESSIONS 2001 10 SESSIONS 01/01/2001
2 RECEIVED IONTOPHORESIS WITH DEXAMETHASONE. 01/01/2001

Database last updated on January 06, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH