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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SHOWER PANEL SHOWER SYSTEMS
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ARJO HOSPITAL EQUIPMENT AB SHOWER PANEL SHOWER SYSTEMS Back to Search Results
Model Number BCA1224-04
Device Problem Failure to Disinfect (1175)
Patient Problem Eye Injury (1845)
Event Date 01/15/2013
Event Type  Injury  
Event Description

As stated by the customer on (b)(6) 2013: caregiver was going to disinfect prelude. When she turned on disinfectant, it sprayed out of the connection of yellow handle into her left eye. Caregiver went to turn on the disinfectant, liquid sprayed out from between the yellow handle and the hose connection.

 
Manufacturer Narrative

The report is being submitted under (b)(4) by the manufacturer arjo hospital equipment (b)(4) on behalf of the importer arjohuntleigh inc. Additional information will be provided upon conclusion of the manufacturer's investigation.

 
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Brand NameSHOWER PANEL
Type of DeviceSHOWER SYSTEMS
Manufacturer (Section D)
ARJO HOSPITAL EQUIPMENT AB
verkstadsvagen 5, box 61
eslov 2412 1
SW 24121
Manufacturer (Section G)
ARJO HOSPITAL EQUIPMENT AB
verkstadsvagen 5
eslov 2412 1
SW 24121
Manufacturer Contact
steve kahn
2349 west lake st.
addison, IL 60101
8003231245
MDR Report Key2956790
MDR Text Key3136719
Report Number9611530-2013-00007
Device Sequence Number1
Product Code ILJ
Combination Product (Y/N)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User facility
Reporter Occupation
Type of Report Initial
Report Date 01/25/2013,01/15/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/25/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberBCA1224-04
Was Device Available For Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/25/2013
Distributor Facility Aware Date01/15/2013
Date Report TO Manufacturer01/25/2013
Date Manufacturer Received01/15/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2002
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 01/25/2013 Patient Sequence Number: 1
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