| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CIDEX? OPA SOLUTION | BIOCIDES SOLUTIONS | ADVANCED STERILIZATION PRODUCTS | MED | 20390 | UNK | * | * |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-02-05 | 0 |
Patient 1
THIS REPORT IS BEING CAPTURED FOR PATIENT #12. UPON FOLLOW-UP, THE CUSTOMER STATED THEY HAVE THREE DIFFERENT LOT NUMBERS: 916100060, 91930008, AND 917200068 BUT DO NOT KNOW WHICH LOT WAS USED WITH ANY OF THE EVENTS. THEY STATED THEY ARE NO LONGER USING CIDEX? OPA SOLUTION FOR CLEANING AND HIGH-LEVEL DISINFECTION AND THAT THE ISSUE HAS SINCE RESOLVED AT THE FACILITY. ASP COMPLAINT REF #: (B)(4).
Patient 1
A CUSTOMER REPORTED MULTIPLE PATIENTS EXPERIENCED BLACK STAINING ON THEIR TONGUES AFTER A DENTAL PROCEDURE USING A TONGUE GUARD THAT WAS HIGH-LEVEL DISINFECTED IN CIDEX? OPA SOLUTION. IT WAS REPORTED THAT THIS EVENT OCCURRED APPROXIMATELY TWELVE DIFFERENT TIMES, AND THE CUSTOMER WAS UNABLE TO PROVIDE EVENT DATES OF EACH INCIDENT OR THE LOT NUMBER OF THE SOLUTION USED. THE CUSTOMER STATED MOST PATIENTS EXPERIENCED BLACK TONGUES AND A BURNING SENSATION IN THEIR MOUTHS AFTER THE PROCEDURE. THE DURATION OF THE SYMPTOMS IS NOT KNOWN; HOWEVER, THE CUSTOMER STATED THE PATIENTS DID NOT RECEIVE ANY MEDICAL ATTENTION AND ALL ARE REPORTED TO BE ?FINE.? THE CUSTOMER WAS NOT WILLING TO PROVIDE ANY FURTHER INFORMATION REGARDING THE EVENTS. UPON FOLLOW-UP REGARDING THEIR CLEANING AND RINSING PROCESS, THE CUSTOMER REPORTED THEY INITIALLY RINSED THEIR INSTRUMENTS UNDER RUNNING WATER AFTER HIGH-LEVEL DISINFECTION TO REMOVE THE SOLUTION, BUT THEN LATER CHANGED THEIR PROCESS TO IMMERSING THE INSTRUMENTS IN WATER FOR ONE MINUTE ONE TIME ONLY. THE CIDEX? OPA SOLUTION INSTRUCTIONS FOR USE (IFU) STATES TO THOROUGHLY RINSE THE DEVICES BY IMMERSING COMPLETELY IN A LARGE VOLUME OF STERILE FRESH WATER FOR A MINIMUM OF ONE MINUTE IN DURATION AND THEN TO REPEAT THE PROCEDURE TWO ADDITIONAL TIMES FOR A TOTAL OF THREE RINSES. IN ADDITION, THE CUSTOMER STATED THEY DO NOT MONITOR THE TEMPERATURE OF THE CIDEX? OPA SOLUTION PRIOR TO USE AS STATED IN THE IFU. ALTHOUGH THERE ARE NO SERIOUS INJURIES REPORTED WITH THESE EVENTS, AS A MATTER OF POLICY, ASP HAS DECIDED TO REPORT CASES WHEN THERE IS PATIENT CONTACT WITH A MEDICAL INSTRUMENT THAT WAS NOT RINSED PROPERLY PER THE IFU AND WHEN THE CIDEX? OPA SOLUTION TEMPERATURE IS NOT BEING MONITORED PRIOR TO USE.