LASER APPLICATOR
Received Jun 5, 2009 · Event occurred Apr 1, 2009
Report 1022819-2009-00150 · MDR key 1404658
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
27 YR
- Blister(s)
- Pain
- Burn, Thermal
Narrative
Description of Event or Problem
THE PT WAS BEING TREATED FOR MUSCLE SPASMS AND INFLAMMATION TO THE BILATERAL TRAPS WITH LASER WHEN THEY RECEIVED A BURN. THE TREATMENT WAS SET FOR 1.44 MINUTES WITH A DOSAGE OF 7.5 J-CM SQUARED. THERE WAS NO PROTECTIVE BARRIER BETWEEN THE SKIN AND THE APPLICATOR. THE APPLICATOR WAS SLIGHTLY ABOVE THE SKIN BUT COULD HAVE BEEN TOUCHING THE PT'S SKIN DURING THE TREATMENT. THE PT DID COMPLAIN OF PAIN DURING THE TREATMENT. AFTER THE TREATMENT, SEVERAL BLISTERS OCCURRED ON BOTH SIDES OF THE TRAPS. THE PT DID NOT REQUIRE MEDICATION OR MEDICAL ATTENTION FOR THE INCIDENT.
Additional Manufacturer Narrative
A DEVICE EVAL WAS PERFORMED BY OUR ENGINEERING DEPARTMENT. ROOT CAUSE IS UNK BECAUSE THE DEVICE PERFORMED TO SPECIFICATION AND TO ITS INTENDED USE. THE ENGINEERING DEPARTMENT DID NOT FIND ANY PROBLEMS WITH THE DEVICE. CONCLUSION: UNIT PASSED ALL TEST CONDUCTED, NO ANOMALIES WERE FOUND. CHECKING UNIT WITH THE LASER APPLICATOR THE UNIT AND APPLICATOR OUTPUT WAS 1.34W'S. THE UNIT MEETS ALL MANUFACTURES SPECIFICATIONS.