MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2017-08-21 for MINNCARE HD 78401-202 manufactured by Medivators, Inc..
[83193092]
A facility reported that an employee was exposed to minncare hd disinfectant underneath their eye after the container slipped and solution bounced up towards their face. It was reported that the affected personnel rinsed her eye in the facility's eye wash station for the full recommended time and did not experience lasting symptoms nor seek additional medical attention. The safety data sheet was obtained by the facility for treatment instructions. The affected personnel was reported to be wearing full ppe, including protective eyewear. This complaint will continue to be monitored in medivators complaint system.
Patient Sequence No: 1, Text Type: N, H10
[83193093]
A facility reported an employee experienced chemical exposure of minncare hd underneath their eye. It was reported that the employee rinsed their eye for the full recommended time and sds was obtained by the facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2017-00035 |
| MDR Report Key | 6808915 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2017-08-21 |
| Date of Report | 2017-08-21 |
| Date of Event | 2017-07-26 |
| Date Mfgr Received | 2017-07-26 |
| Date Added to Maude | 2017-08-21 |
| 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 | ALEX NELSON |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635094799 |
| Manufacturer G1 | MEDIVATORS, INC. |
| 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 | MINNCARE HD |
| Generic Name | DISINFECTANT |
| Product Code | NIH |
| Date Received | 2017-08-21 |
| Model Number | 78401-202 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS, INC. |
| Manufacturer Address | 14605 28TH AVE N MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-21 |