MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-17 for CAVIWIPE1 XL 12/CS 13-5150 manufactured by Metrex Research.
[114279052]
It was reported that the two employees reported to employee health to be seen and evaluated. Complainant has been contacted multiple times for further information, but has remained unresponsive no further information available. No patient information was provided in regards to age, weight, ethnicity and race. Date of event was not provided. No information was provided in regards to lot number, therefore device manufacturing date could not be determined. The product involved in the alleged incident was not returned and no lot number was provided; therefore no further evaluation could be done.
Patient Sequence No: 1, Text Type: N, H10
[114279053]
A healthcare facility reported that two employees are suffering respiratory illness congestion and headaches which caused an asthmatic attack. The first employee developed a headache. The second employee had congestion and a headache.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722021-2018-00002 |
| MDR Report Key | 7696318 |
| Date Received | 2018-07-17 |
| Date of Report | 2018-07-17 |
| Date Mfgr Received | 2018-07-17 |
| Date Added to Maude | 2018-07-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PAULO CALLE |
| Manufacturer Street | 1717 W COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167752 |
| 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 | 0 |
| Brand Name | CAVIWIPE1 XL 12/CS |
| Generic Name | SURFACE DISINFECTANT |
| Product Code | LRJ |
| Date Received | 2018-07-17 |
| Catalog Number | 13-5150 |
| 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 | 2018-07-17 |