IONTOPHORESIS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-07 for IONTOPHORESIS manufactured by Unk.

Event Text Entries

[110616373] While physical therapy for medial epicondylitis in my left elbow, an iontophoresis treatment was administered by the physical therapist. During this treatment, i experienced pain in my left wrist, and discomfort which progressed to numbness in my left hand. The treatment lasted about 15 minutes, however this pain lasted for about 4 hours, and the numbness and discomfort continued for about 2 hours after the treatment ended. Iontophoresis: (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5077707
MDR Report Key7582286
Date Received2018-06-07
Date of Report2018-06-05
Date of Event2018-06-05
Date Added to Maude2018-06-08
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameIONTOPHORESIS
Generic NameIONTOPHORESIS DEVICE
Product CodeEGJ
Date Received2018-06-07
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-06-07

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