Description of Event or Problem · 1
PATIENT REPORTED TO HK (B)(4) THAT HE RECEIVED TREATMENT (B)(6) 2013 WITH GDPG: NO RUBBER DAM, OR COTTON ROLLS WERE USED. DURING THE APPLICATION, THE GUM TISSUE OF THE PATIENT WAS NOT PROTECTED FROM EXPOSURE TO GDPG, SO THAT THE GUMS MIGHT BE EXPOSED TO THE GEL THE ENTIRE TIME. RINSING WITH WATER WAS ONLY VERY SHORT. THE PATIENT HAD RECEIVED A CONNECTIVE TISSUE GRAFT A FEW MONTHS AGO IN THE AREA OF 13 - 16, TEETH 14 AND 15 CERVICALS WERE SENSITIVE AND THEREFORE THE OFFICE DECIDED TO TREAT USING GDPG. ON THE DAY OF TREATMENT, THE PATIENT FELT A STRONG BURNING SENSATION IN THE TREATMENT AREA. LATER THAT EVENING OF THE DAY OF TREATMENT, THERE APPEARED ON THE GINGIVAL, IN THE TREATED AREA, A GRAYISH BROWN LESION. THE DENTIST EVALUATED AREA ON (B)(6) 2013, AND SUSPECTED AN ALLERGIC REACTION. HE PRESCRIBED FOR THE PATIENT SOLCOSERYL GEL FOR FURTHER TREATMENT; THE GEL SHOULD BE APPLIED 3 - 4 TIMES PER DAY. TELEPHONE CONVERSATION WITH (B)(6), (B)(4) 2013: PATIENT STATES HE HAS COMPLETELY RECOVERED AND DOES NOT HAVE ANY LASTING CHANGES. THE GUM IS COMPLETELY REGENERATED AND ROSY AND ALSO WITHOUT DEGRADATION OF THE CONNECTIVE TISSUE GRAFT AT THE TREATED SITE. THE EFFECT OF THE PRODUCT GDPG IS STILL PROVIDED, I. E. THE TREATED TOOTH IS PAIN-FREE AND THE PATIENT IS VERY SATISFIED WITH THE OUTCOME OF TREATMENT EXCEPT FOR THE BURNS CAUSED BY THE IMPROPER APPLICATION. THE DENTIST HAS ACCEPTS THE MISUSE ACCORDING TO PATIENT AND DOES NOT BELIEVE THAT IT IS AN ALLERGIC REACTION, ALTHOUGH HE STATED TO THE PATIENT, THAT HE 'NEVER' HAD SUCH A REACTION TO THE PRODUCT BEFORE. REF MFR # 9610902-2013-00118.