MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-07-15 for MAXICIDE 0104-LGL 1044681 manufactured by Medical Chemical Corporation.
[16106677]
Received a report from distributor on 7/6/09. A dental office employee accidentally got a drop of the product in her eye while treating a pt and subsequently had minor irritation. Distributor was contacted who directed to flush out eye for 15 minutes. Employee was encouraged by vendor to seek medical care. Employee was sent to the er where the eye was flushed and the employee released with eye drops. Eye is slightly red but fine. Diagnosis or reason for use: disinfection of medical instruments.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5012126 |
| MDR Report Key | 1429335 |
| Date Received | 2009-07-15 |
| Date of Report | 2009-07-14 |
| Date of Event | 2009-06-29 |
| Date Added to Maude | 2009-08-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAXICIDE |
| Generic Name | GLUTARALDEHYDE, 2.65% |
| Product Code | IFT |
| Date Received | 2009-07-15 |
| Model Number | 0104-LGL |
| Catalog Number | 1044681 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL CHEMICAL CORPORATION |
| Manufacturer Address | TORRANCE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2009-07-15 |