FDA.reportPublic FDA data

MAUDE MDR 1900987

MDR report key
1900987
Report number
MW5018198
Event key
0
Event type
3
Date of event
2010-10-05
Date received
2010-11-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HYBRESISNONEEMPIEGJ117114-MACHINE/ISSU82675-PATCH N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-11-1101. O

Event Narratives#

D

Patient 1

PT HAD HYBRESIS/IONTOPHORESIS AT LAST PT VISIT (B)(6) 2010 - 10TH INTO TREATMENT, USING HYBRESIS 9 OUT OF 10 TIMES-. PT REPORTS THAT SHE LEFT THAT PATCH ON FOR THE ALLOCATED 2 HOURS FOLLOWING HER TREATMENT SESSION, WHEN SHE TOOK THE PATCH OFF SHE REPORTS THAT THE ELECTRODE WAS BLACK AND DISCOLORED. LATER HER SKIN PIGMENTATION DARKENED/REDDENED IN THE AREA WHERE THE PATCH HAD BEEN. PATCH WAS THROWN AWAY BY PT.