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U.S. Department of Health and Human Services

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

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MEDIVATORS RAPICIDE PA; HIGH LEVEL DISINFECTANT Back to Search Results
Model Number ML02-0117
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Skin Irritation (2076); Chemical Exposure (2570)
Event Date 08/22/2018
Event Type  Injury  
Manufacturer Narrative
It was reported a biomed at the facility spilled rapicide pa part a between their index finger and thumb when adding rapicide pa to their automated endoscope reprocessor.The biomed experienced some irritation.The biomed called medivators to report the incident, medivators technical service read the safety measures on the rapicide pa safety data sheet.The biomed flushed their hand with water.It is unknown if the user was wearing personal protective equipment.The medivators safety data sheet, instructions for use, and label all instructs the users to wear protective gloves when handling rapicide pa part a.This complaint will continue to be monitored in the medivators complaint system.
 
Event Description
It was reported a biomed at the facility was exposed to rapicide pa part a between their index finger and thumb.
 
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Brand Name
RAPICIDE PA
Type of Device
HIGH LEVEL DISINFECTANT
Manufacturer (Section D)
MEDIVATORS
14605 28th ave n
plymouth MN 55447
Manufacturer (Section G)
MEDIVATORS
14605 28th ave n
plymouth MN 55447
Manufacturer Contact
lauren johnson
14605 28th ave n
plymouth, MN 55447
7635533349
MDR Report Key7895460
MDR Text Key120965244
Report Number2150060-2018-00062
Device Sequence Number1
Product Code FEB
UDI-Device Identifier00677964063619
UDI-Public00677964063619
Combination Product (y/n)N
PMA/PMN Number
K082988
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial
Report Date 09/20/2018
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 Other
Device Model NumberML02-0117
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/22/2018
Initial Date FDA Received09/20/2018
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 Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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