| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TOOTHETTE? ORAL CARE | ORAL SWAB | SAGE PRODUCTS LLC | KXF | 6070-X | 6070-X | 56078 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-10-24 | 0 |
Patient 1
REPORTER DISCARDED THE INVOLVED PRODUCT AND DID NOT PROVIDE PHOTOGRAPHS, HOWEVER, PROVIDED LOT INFORMATION. PRODUCTION HISTORY RECORDS FOR THE REPORTED LOT NUMBER WERE REVIEWED AND ALL IN-PROCESS CHECKS INDICATED PASSING RESULTS. THE ROOT CAUSE COULD NOT BE DETERMINED. POTENTIAL ROOT CAUSES CAN BE ATTRIBUTED TO THE FORCE APPLIED BY THE CAREGIVER TO THE SWAB TO REMOVE IT FROM THE PATIENT'S MOUTH WHEN A MOUTH SPASM RESULTED IN BITING DOWN ON THE STICK OF THE SWAB.
Patient 1
REPORT RECEIVED OF FOAM DISENGAGEMENT DUE TO BITING. ON (B)(6) 2017, ORAL CARE WAS PERFORMED ON A MALE PATIENT WITH A MEDICAL HISTORY OF SPASTIC QUADRIPLEGIA CAUSED BY PROGRESSIVE BRAIN DISEASE. THE REPORTER STATED THE PATIENT BIT DOWN ON THE STICK AND THE GREEN FOAM DISENGAGED FROM THE STICK AFTER THE NURSE TRIED TO PULL THE STICK OUT OF THE PATIENT'S MOUTH. THE REPORTER STATED THE FOAM WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S ORAL CAVITY AND NO INJURY OCCURRED TO THE PATIENT OR NURSE. THE REPORTER STATED THE INCIDENT OCCURRED DURING INITIAL USE OF THE PRODUCT AND THE FACILITY STAFF WERE AWARE THE INSTRUCTIONS FOR USE STATE DO NOT ALLOW PATIENT TO BITE DOWN ON SWAB. THE DEVICE WAS DISCARDED AND NO PICTURES WERE AVAILABLE. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.