inforMED
MalfunctionEGJ

HYBRESIS

Received Jan 27, 2010 · Event occurred Dec 15, 2009

Report 1721293-2010-00001 · MDR key 1590455

Device

Generic name

Hybresis Treatment Patch

Manufacturer

Empi

Catalog number

199589-001

Product problems

  • Insufficient Device Problem Information

Patient

Not reported

  • Burn, Thermal

Narrative

Description of Event or Problem

IT WAS REPORTED TO EMPI THAT A PT WAS BEING TREATED FOR ACHILLES TENDONITIS, USING DEXAMETHOSONE 1.5 ML SODIUM PHOSPHATE AND RECEIVED A SMALL BURN. NO MEDICAL INTERVENTION WAS REQUIRED.

Additional Manufacturer Narrative

EVAL METHOD AND RESULTS: WE ARE UNABLE TO EVALUATE AS NO PRODUCT WAS RETURNED; THE PT DISPOSED OF THE ELECTRODE. A FOLLOW-UP REPORT WILL BE SUBMITTED IF MORE INFO BECOMES AVAILABLE.