FDA Adverse Event
Other
Summary report: N
ZPREMIER
MDR report key: 1664703
·
Received April 7, 2010
Report
- Report Number
- 2511556-2010-00002
- Event Type
- Other
- Date Received
- April 7, 2010
- Date of Event
- January 19, 2010
- Report Date
- March 15, 2010
- Manufacturer
- PREMIER DENTAL PRODUCTS CO.
- Product Code
- MVL
- PMA / PMN Number
- K083695
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
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 · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZPREMIER | RETRACTION PASTE | MVL | PREMIER DENTAL PRODUCTS CO. | 5802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other | SEPTOCAINE BLOCK| METHYL METHACRYLATE TEMP| RETRACTION CORD| EUGENOL CEMENT| ZINC OXIDE |