MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-11-02 for EXTRUDE WASH 28414 manufactured by Kerr Corporation.
[15577005]
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 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 indications of any further health concerns.
Patient Sequence No: 1, Text Type: D, B5
[15870703]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1815757-2011-00004 |
| MDR Report Key | 2320046 |
| Report Source | 05 |
| Date Received | 2011-11-02 |
| Date of Report | 2011-10-03 |
| Date of Event | 2011-09-29 |
| Date Mfgr Received | 2011-10-03 |
| Date Added to Maude | 2011-11-02 |
| 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 Contact | MR. ORLANDO TADEO, JR. |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167419 |
| Manufacturer G1 | KERR CORPORATION |
| Manufacturer Street | 28200 WICK ROAD |
| Manufacturer City | ROMULUS MI 48174 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 48174 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXTRUDE WASH |
| Generic Name | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL |
| Product Code | EID |
| Date Received | 2011-11-02 |
| Catalog Number | 28414 |
| Lot Number | 1-1130 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KERR CORPORATION |
| Manufacturer Address | 28200 WICK ROAD ROMULUS MI 48174 US 48174 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-11-02 |