MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2017-04-04 for RENALIN 100 COLD STERILANT 78397-846 manufactured by Medivators.
[71682548]
The facility reported an employee splashed renalin 100 cold sterilant on their hand. The employee did not initially realize until he noticed a dime-size white spot on his finger. Medivators ra followed up with the employee at the facility in response to the chemtrec report. The employee reported rinsing his finger for about thirty minutes and the symptoms went away. The employee reported wearing dry latex gloves, and does not know how the chemical reached his skin. No additional medical attention was sought and the employee's current condition is fine. This event could potentially lead to illness or injury. This complaint will continue to be monitored in the medivators complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[71682549]
Facility reported an employee splashed renalin 100 on hand and experienced chemical exposure symptoms such as discoloration of the skin of his fingers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2017-00015 |
| MDR Report Key | 6458160 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2017-04-04 |
| Date of Report | 2017-04-04 |
| Date of Event | 2017-03-11 |
| Date Mfgr Received | 2017-03-11 |
| Date Added to Maude | 2017-04-04 |
| 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 | SADIE MARTIN |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer G1 | MEDIVATORS |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RENALIN 100 COLD STERILANT |
| Generic Name | MEDICAL DEVICE DISINFECTANT |
| Product Code | LRJ |
| Date Received | 2017-04-04 |
| Model Number | 78397-846 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS |
| Manufacturer Address | 14605 28TH AVE N MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-04 |