MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-07 for RAPICIDE PA ML02-0117 manufactured by Medivators.
[144278273]
It was reported an employee at the facility experienced exposure symptoms after handling rapicide pa. The employee called medivators customer care and reported after picking up a cap for rapicide pa they experienced tingling and burning on their thumb and middle finger. The employee reported the two fingers turned white and flushed the affected area with water. Medivators ra followed up with the employee and supplied the safety data sheet. The employee was not wearing proper protective equipment. The medivators safety data sheet, instructions for use and label instructs the users to wear protective gloves when handling rapicide pa. The employee stated after a few hours her fingers were fine and no longer had exposure symptoms. This complaint will continue to be monitored in the medivators complaint handling system.
Patient Sequence No: 1, Text Type: N, H10
[144278274]
It was reported an employee at the facility experienced exposure symptoms after handling rapicide pa.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2019-00037 |
| MDR Report Key | 8586508 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-07 |
| Date of Report | 2019-05-07 |
| Date of Event | 2019-04-11 |
| Date Mfgr Received | 2019-04-11 |
| Date Added to Maude | 2019-05-07 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAUREN JOHNSON |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer G1 | MEDIVATORS |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPICIDE PA |
| Generic Name | HIGH LEVEL DISINFECTANT |
| Product Code | FEB |
| Date Received | 2019-05-07 |
| Model Number | ML02-0117 |
| 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 PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-07 |