Specific patient information with regard to age and weight was not provided.The patient had experienced sensitivity and required a root canal for treatment of the symptoms.To date, the patient has fully recovered and is doing fine.The product involved in the alleged incident was not returned and no lot number was provided; therefore, no evaluation can be conducted.
|
The doctor's office had initially alleged that for an unknown lot number of sonicfill, approximately seven (7) patients had experienced sensitivity after placement; however, specific patient or incident information could not be recalled.During a follow up phone call on 08/13/14, it was discovered that two (2) additional lot numbers 5044576 and 5091596 were also associated with the alleged incident.Although the office identified three (3) different lots associated with the sensitivity, the office could not verify which lot was used on any of the patients.A visual evaluation was performed on the returned product from the two (2) provided lots #5044576 and #5091596, yielding results within specifications.A dhr review indicated that there were no deviations from the manufacturing process.In addition, no similar complaints were received with regard to these lots.
|