ZPREMIER
Received Apr 7, 2010 · Event occurred Jan 19, 2010
Report 2511556-2010-00002 · MDR key 1664703
Device
Generic name
Retraction Paste
Manufacturer
Premier Dental Products Co.Catalog number
9007093
Lot number
5802
Product problems
- Patient-Device Incompatibility
Patient
53 YR
- Hypersensitivity/Allergic reaction
- Inflammation
- Pain
- Tissue Damage
- Toxicity
- Reaction
Narrative
Additional Manufacturer Narrative
THE DENTIST SAID HE DID NOT HAVE THE PRODUCT ANY LONGER. THEREFORE, NO PRODUCT WAS RETURNED TO THE MFR FOR EVAL. THE DENTIST ALSO REPORTED HE CONTINUES TO USE TRAXODENT AND THAT HE LIKES IT VERY MUCH. ADDITIONAL INFO FROM VOLUNTARY REPORT: TRAXODENT .7G.; 1 X TOPICAL. THERAPY DATE: (B)(6) 2010. GINGIVAL RETRACTION. EVENT ABATED AFTER USE, STOPPED, OR DOSE REDUCED: YES. THE REPORTER DOES WANT THEIR IDENTITY DISCLOSED.
Description of Event or Problem
DENTIST PACKED GINGIVAL SULCUS #30 FOR RETRACTION WITH TRAXODENT. PT HAD A LOCAL ALLERGIC/TOXIC REACTION CONSISTENT OF PAIN, INFLAMMATION, AND SLUFFING OF TISSUE. PT GIVEN ANTIBIOTIC BY MD TWO WEEK HEALING PERIOD AS REPORTED BY THE DENTIST.