MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-27 for CAVICIDE 13-1024 manufactured by Metrex Research.
[118405951]
The patient saw an optometrist who prescribed antibiotics and dexamethosone eye drops. Pain has decreased and vision is no longer blurry. She is expected to make a full recovery. No patient information was provided in regards to age, weight, ethnicity and race. 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
[118405952]
A staff member got cavicide in both her eyes while cleaning, pain and blurry vision ensued. No personal protective equipment was worn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722021-2018-00004 |
| MDR Report Key | 7820484 |
| Date Received | 2018-08-27 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-07-30 |
| Date Mfgr Received | 2018-08-27 |
| Date Added to Maude | 2018-08-27 |
| 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. 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 | CAVICIDE |
| Generic Name | SURFACE DISINFECTANT |
| Product Code | LRJ |
| Date Received | 2018-08-27 |
| Catalog Number | 13-1024 |
| 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 | 2018-08-27 |