EXTRUDE WASH
Received Nov 1, 2011 · Event occurred Sep 29, 2011
Report 1815757-2011-00003 · MDR key 2318223
Device
Generic name
Syringe, Restorative And Impression Material
Manufacturer
Kerr CorporationCatalog number
28418
Lot number
9-1177
Product problems
- Improper or Incorrect Procedure or Method
Patient
Not reported
- Rash
Narrative
Additional Manufacturer Narrative
A PHYSICAL TESTS INCLUDING COMPRESSION SET AND WORK TIME WERE PERFORMED ON THE RETURNED MATERIAL WHICH INDICATED THAT THE PRODUCT MET SPECIFICATIONS. TIP OF THE RETURNED CARTRIDGE APPEARS TO HAVE BEEN MODIFIED BY THE DOCTOR AND THE EXTRUDE WASH RETURNED WITH AN INCORRECT TIP ATTACHED TO IT.
Description of Event or Problem
ON (B)(6), DOCTOR PREPPED A PATIENT FOR A CROWN. HE USED Z100 FLOWABLE FOR TEMPORARY MATERIAL AND USED NO TEMPORARY CEMENT. THE NEXT DAY (B)(6), 2011 THE PATIENT CALLED COMPLAINING OF A RASH ON THE SIDE OF HER TONGUE AND RETURNED TO THE DOCTOR'S OFFICE. THE DOCTOR ADVISED HER TO TAKE BENADRYL AND GAVE HER A PRESCRIPTION FOR ORABASE. THE DOCTOR CALLED THE PATIENT SEVERAL TIMES SINCE THE INCIDENT, BUT DID NOT RECEIVE A RETURN CALL. SHE ASSUMES EVERYTHING IS OK. THE DOCTOR SAID THE PATIENT WAS PROBABLY ALLERGIC TO VINYL. THERE HAVE BEEN NO INDICATION OF ANY FURTHER HEALTH CONCERNS.
Additional Manufacturer Narrative
AN EVALUATION OF THE RETURNED PRODUCT WAS CONDUCTED INCLUDING COMPRESSION SET AND WORK TIME. RESULTS OF THE EVALUATION INDICATES THE PRODUCT MET SPECIFICATIONS. IN ADDITION, THE TIP OF THE RETURNED CARTRIDGE APPEARS TO HAVE BEEN MODIFIED BY THE DOCTORAND IT WAS NOT THE CORRECT TIP THAT WAS SUPPOSED TO HAVE BEEN USED WITH THIS PRODUCT.
Description of Event or Problem
ON (B)(6), A DOCTOR PREPPED A PATIENT FOR A CROWN. HE USED Z100 FLOWABLE FOR TEMPORARY MATERIAL AND USED NO TEMPORARY CEMENT. THE NEXT DAY (B)(6), 2011 THE PATIENT CALLED COMPLAINING OF A RASH ON THE SIDE OF HER TONGUE AND RETURNED TO THE DOCTOR'S OFFICE. THE DOCTOR ADVISED HER TO TAKE BENADRYL AND GAVE HER A PRESCRIPTION FOR ORABASE. THE DOCTOR CALLED THE PATIENT SEVERAL TIMES SINCE THE INCIDENT, BUT DID NOT RECEIVE A RETURN CALL. SHE ASSUMES EVERYTHING IS OK. THE DOCTOR SAID THE PATIENT WAS PROBABLY ALLERGIC TO VINYL. THERE HAVE BEEN NO INDICATION OF ANY FURTHER HEALTH CONCERNS.