MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-02 for KENDRICK KE-823 manufactured by Emergency Products And Research.
[899499]
The prod was a kendrick other device for extrication - k. O. D. E. -. The prod is a spinal immobilization device. One of the wooden slats that makes up the device broke after it was applied to the pt, and while removing the pt from the vehicle. The device is made up of multiple wooden slats, therefore, there was no injury to the pt as a result of the failure of the equipment. The equipment was removed from svc immediately after removal from the pt. The failure of the equipment was reported to the vendor from whom the equipment was purchased. Dates of use: first use 2008. Reason for use: used for vehicle extraction of pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5007511 |
| MDR Report Key | 1069174 |
| Date Received | 2008-07-02 |
| Date of Report | 2008-07-02 |
| Date of Event | 2008-06-26 |
| Date Added to Maude | 2008-07-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KENDRICK |
| Generic Name | KENDRICK'S OTHER DEVICE FOR EXTRACTION - K.O.D.E. - |
| Product Code | IQF |
| Date Received | 2008-07-02 |
| Returned To Mfg | 2008-07-02 |
| Model Number | KE-823 |
| Lot Number | 1024 |
| ID Number | KE-823 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1037169 |
| Manufacturer | EMERGENCY PRODUCTS AND RESEARCH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-02 |