MAUDE Adverse Event Report: DJO, LLC DUPEL DUAL CHANNEL IONTOPHORESIS SYSTEM; DEVICE, IONTOPHORESIS, OTHER USES

Device Problem Insufficient Information (3190)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 05/19/2017

Event Type  malfunction  

Event Description

Blister under right shoulder pad; iontophoresis with dexamethasone 4mg/ml.

• Brand Name: DUPEL DUAL CHANNEL IONTOPHORESIS SYSTEM
• Type of Device: DEVICE, IONTOPHORESIS, OTHER USES
• Manufacturer (Section D): DJO, LLC; 1430 decision st.; vista CA 92081
• MDR Report Key: 6893907
• MDR Text Key: 87356304
• Report Number: 6893907
• Device Sequence Number: 1
• Product Code: EGJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2017,09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2017
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Outcome(s): Other