DUPEL IONTOPHORESIS DEVICE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-17 for DUPEL IONTOPHORESIS DEVICE * manufactured by Empi.

Event Text Entries

[2522421] A treatment of iontophoresis was used for this patients left middle "trigger finger". The dispersive pad was placed vertically and following the palm along the path of the flexor tendons, from the a1 pulley, proximally. A 2. 0 cc pad was chosen and dexamethasone was dispersed on the pad. This was then placed on the patients palm and a ground pad placed on the forearm. The machine was turned on and the current placed at 1. 2 ma. The patient was asked about her tolerance to the current. She reported she "felt it all the way through the pad", but it was fine. This was not an unusual comment, as the treatment is usually somewhat uncomfortable. Following 3 to 4 minutes, she was left unattended for approximately 7 minutes. I then returned to check on her. At that time she said she felt it more intensely. I stopped the current to inspect under the pad. The volar aspect of her hand appeared normal. I turned the palm down and moved her gold wedding ring to inspect. The ring was on the adjacent ring finger. There was a pinhead size black spot on her skin under the ring. She stated it hurt. The treatment was stopped, she removed her ring. Triple antibiotic was placed on the wound with a sterile qtip, and sterile gauze was placed over this. A cold pack was then placed on her hand for 10 minutes. She left the clinic at that time to see an md. "the patient states that part of the patch was touching her finger. The patient also stated that that some of "goop" extended over onto the ring finger causing conduction to occur between the electrical probe that they were using and the metal wedding band. This did cause a burn to the proximal phalange #4 left upper extremity, and a discoloration to the wedding ring itself. "======================manufacturer response for dupel iontophoresis system, (brand not provided) (per site reporter). ======================please return the unit for internal evaluation. Company to replace this equipment.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2466956
MDR Report Key2466956
Date Received2012-02-17
Date of Report2012-02-17
Date of Event2012-02-10
Report Date2012-02-17
Date Reported to FDA2012-02-17
Date Added to Maude2012-02-24
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDUPEL IONTOPHORESIS DEVICE
Generic NameDUPEL IONTOPHORESIS SYSTEM
Product CodeKTB
Date Received2012-02-17
Returned To Mfg2012-02-17
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorOTHER
Device AvailabilityR
Device Sequence No1
Device Event Key0
ManufacturerEMPI
Manufacturer Address205 HWY 22 EAST PO BOX 709 CLEAR LAKE SD 57226 US 57226


Patients

Patient NumberTreatmentOutcomeDate
10 2012-02-17

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