MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 2010-04-07 for ZPREMIER 9007093 manufactured by Premier Dental Products Co..
[1300212]
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.
Patient Sequence No: 1, Text Type: D, B5
[8568555]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2511556-2010-00002 |
| MDR Report Key | 1664703 |
| Report Source | 04,05,06 |
| Date Received | 2010-04-07 |
| Date of Report | 2010-03-15 |
| Date of Event | 2010-01-19 |
| Date Mfgr Received | 2010-03-15 |
| Device Manufacturer Date | 2009-05-01 |
| Date Added to Maude | 2012-03-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1710 ROMANO DR. |
| Manufacturer City | PLYMOUTH MEETING PA 19462 |
| Manufacturer Country | US |
| Manufacturer Postal | 19462 |
| Manufacturer Phone | 6102396015 |
| Manufacturer G1 | B.J.M. LABORATORIES LTD. |
| Manufacturer Street | 12 HASSADNA ST. INDUSTRIAL PARK |
| Manufacturer City | OR-YEHUDA 60200 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 60200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZPREMIER |
| Generic Name | RETRACTION PASTE |
| Product Code | MVL |
| Date Received | 2010-04-07 |
| Catalog Number | 9007093 |
| Lot Number | 5802 |
| Device Expiration Date | 2011-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PREMIER DENTAL PRODUCTS CO. |
| Manufacturer Address | PLYMOUTH MEETING PA 19462 US 19462 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-04-07 |