MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-12-07 for CAVICIDE manufactured by Metrex Research.
[61697039]
A complainant alleged that he had experienced a chemical burn and an intense burning pain from exposure to cavicide. The complainant alleged that a doctor and a nurse in the emergency room at university medical center (umc) had sprayed cavicide directly into his open wound multiple times before sutures were applied. The severe burning pain increased in intensity as more cavicide spray was applied to the open wound. It was noted that the complainant returned to the examination room and demanded to have the sutures removed and his wound rinsed. The hospital staff removed the sutures, rinsed the wound with water and re-sutured it. Lidocaine was applied to the wound. Days later, the complainant went to the (b)(6) burn unit and was reported that he did obtain satisfactory treatment there. The product involved in the alleged incident was not returned and no lot was provided; therefore, no investigation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
[61697040]
A patient had experienced a chemical burn and an intense burning pain from exposure to cavicide. The complainant alleged that a doctor and a nurse in the emergency room at university medical center (umc) had sprayed cavicide directly into his open wound multiple times before sutures were applied.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722021-2016-00002 |
| MDR Report Key | 6152222 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-12-07 |
| Date of Report | 2016-11-28 |
| Date of Event | 2015-08-03 |
| Date Mfgr Received | 2016-11-28 |
| Date Added to Maude | 2016-12-07 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 | 3 |
| Brand Name | CAVICIDE |
| Generic Name | SURFACE DISINFECTANT |
| Product Code | LRJ |
| Date Received | 2016-12-07 |
| Operator | PHYSICIAN |
| 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 | 2016-12-07 |