IOMED COMPANION 80

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-24 for IOMED COMPANION 80 manufactured by Iomed, Inc..

Event Text Entries

[16717476] Iomed companion 80 was used to deliver dexamethasone to right shoulder for bursitis/tendonitis. First use beginning in 2008 was problem free. Second application was initiated two days later. Each application was required to be worn for 24 hrs. Approx 26 hrs after the 2nd application, the patch was removed and discoloration was identified that included reddening/bruising around the perimeter of the patch and white spots in the central area of the + end of the patch. There had been no pain associated with this wearing. The following day, the white spots had turned purple/black and the reddish areas appeared more like ordinary bruising. There was still no pain of the skin, but the shoulder was generally more painful internally. A phone call was logged with the therapist reporting this adverse event on friday, 3/21/08. On monday, 03/24/08, the therapist was seen at a regularly scheduled appt. This therapist noted that he had seen such results on 2-3 prior occasions but had not reported them because he could not determine what the root cause was. Frequency: 24 hrs, route: iontophoresis; dates of use: two days in 2008; diagnosis or reason for use: bursitis/tendonitis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5006007
MDR Report Key1019024
Date Received2008-03-24
Date of Report2008-03-24
Date of Event2008-03-20
Date Added to Maude2008-04-01
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameIOMED COMPANION 80
Generic NameIONTOPHORESIS
Product CodeKTB
Date Received2008-03-24
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key987069
ManufacturerIOMED, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2008-03-24

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