MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-05-14 for PREMIER 9007091 manufactured by Premier Dental Products Co..
[1487857]
Dentist was working on tooth #31 and numbed the patient with polocaine before beginning the procedure. The patient's face instantly swelled after administering the traxodent retraction material. Patient had an allergic reaction and was sent to the emergency room where she was given benadryl iv. On (b)(6) 2010, the office reported the patient was still sore and swollen but doing much better than the day before. The office has used traxodent on other patients without any problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2511556-2010-00003 |
| MDR Report Key | 1691563 |
| Report Source | 05,06 |
| Date Received | 2010-05-14 |
| Date of Report | 2010-04-21 |
| Date of Event | 2010-04-21 |
| Date Mfgr Received | 2010-04-21 |
| Date Added to Maude | 2012-03-15 |
| 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 | PREMIER |
| Generic Name | RETRACTION PASTE |
| Product Code | DYH |
| Date Received | 2010-05-14 |
| Catalog Number | 9007091 |
| Lot Number | 5813 |
| Device Expiration Date | 2011-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2010-05-14 |