PEPGEN P-15 PUTTY
Received Jan 16, 2009 · Event occurred Oct 9, 2008
Report 3006146445-2008-00166 · MDR key 1291583
Device
Product problems
- Device, removal of (non-implant)
Patient
UNK
- Swelling
- Foreign body, removal of
- Therapy/non-surgical treatment, additional
- Treatment with medication(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT DEVELOPED UNSPECIFIED SWELLING THE DAY FOLLOWING PLACEMENT OF PEPGEN P-15 PUTTY INTO AN EXTRACTION SITE. THE PATIENT WAS PLACED ON PENICILLIN AND REFERRED TO AN ORAL SURGEON WHO RECOMMENDED THAT THE MATERIAL BE REMOVED AND THE PATIENT BE PLACED ON A DIFFERENT ANTIBIOTIC. THE GRAFTING MATERIAL WAS REMOVED, THOUGH THE PATIENT CONTINUED TREATMENT WITH PENICILLIN.
Additional Manufacturer Narrative
WHILE IT IS UNKNOWN IF THE PEPGEN USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT IS REPORTABLE. THE LOT NUMBER WAS PROVIDED FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.