MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-06-20 for EMEA CIDEX? OPA SOLUTION 20391 manufactured by Advanced Sterilization Products.
| Report Number | 2084725-2019-00888 |
| MDR Report Key | 8719370 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-06-20 |
| Date of Report | 2019-05-23 |
| Date of Event | 2019-05-19 |
| Date Mfgr Received | 2019-09-16 |
| Device Manufacturer Date | 2018-06-21 |
| Date Added to Maude | 2019-06-20 |
| 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 | 949453-639 |
| Manufacturer G1 | ADVANCED STERILIZATION PRODUCTS |
| 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 | EMEA CIDEX? OPA SOLUTION |
| Generic Name | BIOCIDES SOLUTIONS |
| Product Code | MED |
| Date Received | 2019-06-20 |
| Returned To Mfg | 2019-06-29 |
| Catalog Number | 20391 |
| Lot Number | 250618170 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED STERILIZATION PRODUCTS |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-06-20 |