*
Received Jan 17, 2006 · Event occurred Nov 19, 2005
Report 2182686-2006-00003 · MDR key 664846
Device
Generic name
Iontophoresis
Manufacturer
EmpiModel number
ACTION PATCHCatalog number
199488-001
Lot number
53033
Product problems
- Unknown (for use when the device problem is not known)
Patient
*
- Burn(s)
- Necrosis
- Pain
- Scar Tissue
- Surgical procedure
- Hospitalization required
Narrative
Description of Event or Problem
PT RECEIVED AN ACTION PATCH FOR QUAD TENDONITIS. PATCH WAS PLACED WITH THE MEDICATED END SECURED TO THE PROXIMAL/LATERAL PORTION OF QUAD TENDON AND THE GROUND PLACED DISTAL AND LATERAL TO PATELLAR TENDON. PT LEFT THERAPY WITHOUT ANY COMPLAINTS OF BURNING OR STINGING. PT REPORTED LATER HAVING BURNING AND STINGING AT THE GROUND END (+) THAT PROGRESSIVELY GOT WORSE THE LONGER THE PATCH WAS ATTACHED. PT DID NOT REALIZE SHE SHOULD TAKE THE PATCH OFF AND THAT THE BURNING WAS NOT NORMAL. PT REPORTED SHE COULD NO LONGER TAKE THE PAIN AND TOOK THE PATCH OFF JUST SHY OF 3 HOURS BEFORE THE PATCH HAD TURNED OFF. PT RETURNED TO THERAPY 2 DAYS BEFORE EVENT DAY AND PRESENTED WITH A 1 CENTIMETER DIAMETER ELECTRICAL BURN WITH UNKNOWN DEPTH OF BURN AND ESCAR (NECROTIC TISSUE) COVERING BURN SITE. PT WAS LATER DIAGNOSED ON EVENT DATE WITH 2ND AND 3RD DEGREE ELECTRICAL BURNS AT THE EMERGENCY ROOM. PT LATER REPORTED SHE HAD THE WOUND CLEANED AND ESCAR EXCISED. THE DOCTOR DID MULTIPLE LAYERS OF SUTURES THROUGH ALL LAYERS OF SKIN. PT REPORTS HAVING APPROX A 1.5 INCH SCAR REMAINING BUT EVERYTHING HAS CLOSED AND HEALED.