MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2008-09-08 for EXTRUDER GUN manufactured by Kerr Corporation.
[948561]
In 2007, kerr corporation was served with a legal summons where the plaintiff, a healthcare worker, alleges severe injuries to her head, neck, back, body and limbs as a result of squeezing the trigger of the dental impression material extruder gun allegedly manufactured by kerr corporation.
Patient Sequence No: 1, Text Type: D, B5
[7893099]
The plaintiff alleges that daily use of the dental extruder gun with excessive force to squeeze the dental impression material out of the gun has caused her severe injury, "sick, sore, lame and otherwise disabled. " she alleges she suffers great pain and anguish of the body and mind which are permanent in nature. The plaintiff seeks compensatory damages for her alleged injuries. The case is being handled by legal counsel.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1815757-2008-00005 |
| MDR Report Key | 1149163 |
| Report Source | 00 |
| Date Received | 2008-09-08 |
| Date of Report | 2007-05-15 |
| Date Mfgr Received | 2007-05-15 |
| Date Added to Maude | 2008-09-09 |
| 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 | ATTORNEY |
| 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 | EXTRUDER GUN |
| Generic Name | SYRINGE, RESTORATIVE & IMPRESSION MATERIAL |
| Product Code | EID |
| Date Received | 2008-09-08 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1165257 |
| Manufacturer | KERR CORPORATION |
| Manufacturer Address | 28200 WICK ROAD ROMULUS MI 48174 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-09-08 |