HYBRESIS 199589-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-10-06 for HYBRESIS 199589-001 manufactured by Empi.

Event Text Entries

[18613430] It was reported to empi that a pt was burned during a hybresis treatment. The pt was being treated for achilles tendonitis. Dexamethesone at 1. 5 ml was used on the negative side, and saline on the positive side. The area was covered by a sock during the treatment. The pt wore the patch home and forgot to remove it and left it on for 4 hours. The pt did not notice the burn until made aware by the therapist at the next visit. The burn was 1/4 inch round and 1/8 inch deep. Pt had no discomfort. An ultrasound was performed prior to the hybresis treatment.
Patient Sequence No: 1, Text Type: D, B5


[18686765] No product returned. This report is being submitted because empi has received a similar complaint that suggests that this device may have malfunctioned in such a way that it would be likely to cause or contribute to a serious injury if the malfunction were to recur.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1721293-2010-00010
MDR Report Key1867761
Report Source06
Date Received2010-10-06
Date of Report2010-07-12
Date of Event2010-01-15
Device Manufacturer Date2009-12-01
Date Added to Maude2011-02-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactDEBBIE MIRANDA
Manufacturer Street205 HWY. 22 E.
Manufacturer CityCLEAR LAKE SD 57226
Manufacturer CountryUS
Manufacturer Postal57226
Manufacturer Phone6058746357
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHYBRESIS
Generic NameHYBRESIS
Product CodeEGJ
Date Received2010-10-06
Model Number199589-001
Lot Number81278
Device Expiration Date2010-09-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerEMPI
Manufacturer Address205 HWY. 22 E. CLEAR LAKE SD 57226 US 57226


Patients

Patient NumberTreatmentOutcomeDate
10 2010-10-06

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