MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-08-10 for CAVIWIPES XL 12/CS 13-1150 manufactured by Metrex Research.
[116807933]
No patient information was provided in regards to 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
[116807934]
A complainant alleged that while using caviwipes the liquid from one of the tissues was flung into her eye when removing from the container. The complainant rinsed her eye after exposure. Eye became red and swollen. Complainant visited an eye doctor who noted an abrasion and was given a contact lens as well as eye drops. Redness and swelling has subsided, but complainant still has sensitivity to light.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722021-2018-00003 |
| MDR Report Key | 7774122 |
| Report Source | USER FACILITY |
| Date Received | 2018-08-10 |
| Date of Report | 2018-08-10 |
| Date of Event | 2018-07-12 |
| Date Mfgr Received | 2018-08-10 |
| Date Added to Maude | 2018-08-10 |
| 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 | 3 |
| Brand Name | CAVIWIPES XL 12/CS |
| Generic Name | SURFACE DISINFECTANT |
| Product Code | LRJ |
| Date Received | 2018-08-10 |
| Catalog Number | 13-1150 |
| 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 | 2018-08-10 |