MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-09 for CAVIWIPES 13-1100 manufactured by Metrex Research.
[62081700]
The affected individual flushed both eyes with water for fifteen (15) minutes and rinsed with saline solution for one (1) hour. The affected individual was seen by urgent care. Neither eye showed signs of abrasion. Keterolac eye drops were prescribed. The affected individual was able to return to work. Four (4) days after the incident, the affected individual indicated she was still experiencing the feeling of "stickers" behind the eye, slight eye sensitivity, and headaches. The affected individual believed the symptoms were caused by the rinsing procedure that was done to her. She believes the side effects will diminish and does not plan on any follow up appointments. The product was not returned and no lot number was provided; therefore, no investigation could be performed.
Patient Sequence No: 1, Text Type: N, H10
[62081701]
A caller indicated that a co-worker had liquid from caviwipes splash in both eyes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722021-2016-00003 |
| MDR Report Key | 6164235 |
| Date Received | 2016-12-09 |
| Date of Report | 2016-11-11 |
| Date of Event | 2016-11-11 |
| Date Mfgr Received | 2016-11-11 |
| Date Added to Maude | 2016-12-09 |
| 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 | 0 |
| Brand Name | CAVIWIPES |
| Generic Name | SURFACE DISINFECTANT |
| Product Code | LRJ |
| Date Received | 2016-12-09 |
| Catalog Number | 13-1100 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2016-12-09 |