MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2008-12-05 for KWIK BITE SENSO KODAK KITB 2700 KODAK manufactured by Kerrhawe Sa.
[973916]
A doctor reported to the dealer that during normal use when the patient bites down on the kwik bite x-ray film holder, it has the potential to break into two pieces exposing the small internal components, which in her opinion could be swallowed by the patient and cause a serious injury. No injuries have been reported.
Patient Sequence No: 1, Text Type: D, B5
[8132008]
The dealer believes that the doctor's office is not using the kwik bite holders correctly and has advised the doctor's office that the patient should not be biting hard on the main body of the device. According to the risk assessment of the product, it is deemed unlikely to break into small pieces. A total kits have been sold annually worldwide for many years now without any incident. This is the first complaint that has ever been reported alleging that the product could cause a serious injury if the patient were to swallow a broken piece. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8031023-2008-00001 |
| MDR Report Key | 1251363 |
| Report Source | 01,05 |
| Date Received | 2008-12-05 |
| Date of Report | 2008-11-09 |
| Date Added to Maude | 2009-03-17 |
| 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 | KERRHAWE SA |
| Manufacturer Street | VIA STRECCE 4 |
| Manufacturer City | BIOGGIO, CH-6934 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-6934 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KWIK BITE SENSO KODAK KITB |
| Generic Name | FILM, X-RAY HOLDER |
| Product Code | EGZ |
| Date Received | 2008-12-05 |
| Model Number | 2700 KODAK |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KERRHAWE SA |
| Manufacturer Address | VIA STRECCE 4 BIOGGIO, CH-6934 SZ CH-6934 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-12-05 |