MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-08-13 for KENDRICK'S OTHER DEVICE FOR EXTRICATION manufactured by Emergency Products & Research.
[2662337]
Our extrication device was used to immobilize a pt. One of the wooden support slats broke (either before application or during, it is unk). As there are several support slats, it did not result in an adverse incident.
Patient Sequence No: 1, Text Type: D, B5
[9879688]
This is the first time this product has had a reported malfunction. Emergency products & research has produced thousands of these products. It is an industry standard. After talking with the reporter, he stated that in 20 years, this is the first time he has encountered a problem with this device. It is an isolated incident. The reporter sent the device back to the distributor. After repeated requests, we have yet to have it returned to us for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002754225-2008-00001 |
| MDR Report Key | 2606792 |
| Report Source | 05 |
| Date Received | 2008-08-13 |
| Date of Report | 2008-07-02 |
| Date of Event | 2008-06-26 |
| Date Mfgr Received | 2008-07-02 |
| Date Added to Maude | 2012-06-12 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JACK SEUBERT |
| Manufacturer Street | 1542 BUTTONWOOD DR |
| Manufacturer City | BIG PINE KEY FL 33043 |
| Manufacturer Country | US |
| Manufacturer Postal | 33043 |
| Manufacturer Phone | 3053046933 |
| Manufacturer G1 | EMERGENCY PRODUCTS & RESEARCH |
| Manufacturer Street | 890 WEST MAIN STREET |
| Manufacturer City | KENT OH 44240 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44240 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KENDRICK'S OTHER DEVICE FOR EXTRICATION |
| Generic Name | KODE 1 RESCUE VEST |
| Product Code | IQF |
| Date Received | 2008-08-13 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EMERGENCY PRODUCTS & RESEARCH |
| Manufacturer Address | KENT OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-13 |