MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-05 for CIDEX? OPA SOLUTION 20390 manufactured by Advanced Sterilization Products.
[185496032]
This report is being captured for patient #7. 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 Sequence No: 1, Text Type: N, H10
[185496033]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-2020-50018 |
| MDR Report Key | 9673859 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date Mfgr Received | 2020-01-13 |
| Device Manufacturer Date | 2000-01-01 |
| Date Added to Maude | 2020-02-05 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. GABRIELA MCLELLAN |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9495030264 |
| Manufacturer G1 | ASP IRVINE MFG |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CIDEX? OPA SOLUTION |
| Generic Name | BIOCIDES SOLUTIONS |
| Product Code | MED |
| Date Received | 2020-02-05 |
| Catalog Number | 20390 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED STERILIZATION PRODUCTS |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |