MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-09 for CAVICIDE 13-1000 manufactured by Metrex Research.
[59557631]
A doctor alleged that a male patient had experienced nausea and vomiting from a dental instrument with tubing that was cleaned with cavicide and used on the patient orally. It was reported that cavicide was left in a reservoir of the tubing and the patient had ingested the liquid. A few hours after the ingestion, the patient had experienced nausea; and nausea progressed to vomiting. The patient was hospitalized for 24 hours. Nausea medication was given to the patient however the doctor did not provide the name of the medication. The doctor saw no change in blood chemistry, kidney function, or stool of patient. There was no follow-up required due to normal lab results and the patient appeared to have fully recovered. The product involved in the alleged incident was not returned and no lot number was provided; therefore no further evaluation can be conducted. Specific information regarding the patient's age was not provided however, the doctor indicated that the patient was over 65 years of age.
Patient Sequence No: 1, Text Type: N, H10
[59557632]
A doctor alleged that a patient had experienced nausea and vomiting from a dental instrument with tubing that was cleaned with cavicide and used on the patient orally.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722021-2016-00001 |
| MDR Report Key | 6091500 |
| Date Received | 2016-11-09 |
| Date of Report | 2016-10-10 |
| Date of Event | 2016-10-10 |
| Date Mfgr Received | 2016-10-10 |
| Date Added to Maude | 2016-11-09 |
| 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 | CAVICIDE |
| Generic Name | SURFACE DISINFECTANT |
| Product Code | LRJ |
| Date Received | 2016-11-09 |
| Catalog Number | 13-1000 |
| Operator | DENTIST |
| 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. Hospitalization; 2. Other | 2016-11-09 |