MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-02-17 for CAVICIDE 13-1000 manufactured by Metrex Research.
[67804225]
The employee was pouring cavicide into containers and soaking microfiber cloths in the solution before using the product as a disinfectant. The employee had to use their inhaler several times in order to resolve the asthmatic attacks. No additional medical attention was required. The age of the employee was not provided.
Patient Sequence No: 1, Text Type: N, H10
[67804226]
A healthcare facility reported that an employee experienced asthmatic attacks following use of cavicide.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722021-2017-00001 |
| MDR Report Key | 6341431 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-02-17 |
| Date of Report | 2017-01-20 |
| Date of Event | 2017-01-20 |
| Date Mfgr Received | 2017-01-20 |
| Date Added to Maude | 2017-02-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARK DZENDZEL |
| Manufacturer Street | 1717 WEST COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167802 |
| Manufacturer G1 | METREX RESEARCH |
| Manufacturer Street | 28210 WICK ROAD |
| Manufacturer City | ROMULUS MI 48174 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 48174 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAVICIDE |
| Generic Name | SURFACE DISINFECTANT |
| Product Code | LRJ |
| Date Received | 2017-02-17 |
| Catalog Number | 13-1000 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | METREX RESEARCH |
| Manufacturer Address | 28210 WICK ROAD ROMULUS MI 48174 US 48174 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-02-17 |