• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVATORS RAPICIDE PA; HIGH LEVEL DISINFECTANT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDIVATORS RAPICIDE PA; HIGH LEVEL DISINFECTANT Back to Search Results
Model Number ML02-0117
Device Problems Fumes or Vapors (2529); Chemical Spillage (2894)
Patient Problem Chemical Exposure (2570)
Event Date 01/05/2018
Event Type  Injury  
Manufacturer Narrative
The facility reported 500 ml of rapicide pa high level disinfectant spilled.It was reported that fumes were inhaled and individuals not wearing proper personal protective equipment (ppe) experienced chemical exposure on their skin.There was an immediate response from the facility and the spill was cleaned according to the safety data sheet.Medivators environmental health and safety manager contacted the facility and provided information regarding proper ventilation and employee exposure monitoring, as requested.Medivators regulatory affairs also followed up with the facility and received confirmation that exposed staff did not have lasting exposure symptoms.The facility plans to address their concerns for ensuring proper air exchanges/ventilation in their space as well as possibly implementing a badge test for staff working in the area where the fumes were present.This complaint will continue being monitored in medivators complaint handling system.
 
Event Description
The facility reported 500 ml of rapicide pa high level disinfectant spilled.It was reported that fumes were inhaled and individuals not wearing proper personal protective equipment (ppe) experienced chemical exposure on their skin.The facility requested information regarding proper ventilation and employee exposure monitoring.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RAPICIDE PA
Type of Device
HIGH LEVEL DISINFECTANT
Manufacturer (Section D)
MEDIVATORS
14605 28th ave n
minneapolis MN 55447
Manufacturer (Section G)
MEDIVATORS
14605 28th ave n
minneapolis MN 55447
Manufacturer Contact
alex nelson
14605 28th ave n
minneapolis, MN 55447
7635094799
MDR Report Key7234044
MDR Text Key98781966
Report Number2150060-2018-00007
Device Sequence Number1
Product Code FEB
UDI-Device Identifier00677964063619
UDI-Public00677964063619
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082988
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial
Report Date 02/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberML02-0117
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/05/2018
Initial Date FDA Received02/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
-
-