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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB UNKNOWN; BATH, HYDRO-MASSAGE
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ARJO HOSPITAL EQUIPMENT AB UNKNOWN; BATH, HYDRO-MASSAGE Back to Search Results
Model Number UNKNOWN
Device Problems Use of Device Problem (1670); Insufficient Information (3190)
Patient Problem Caustic/Chemical Burns (2549)
Event Date 02/20/2022
Event Type  Injury  
Event Description
Arjo was notified about an event with involvement of the system 2000 bath.It was reported that a resident was showered with the wrong shower handle which means that the patient was showered with arjo clean disinfectant.It was indicated that the resident sustained burns and had to go to the hospital for 10 days to be treated.
 
Manufacturer Narrative
Device involved in the incident is unknown.
 
Event Description
Arjo was notified about an event where it was reported that a resident was showered with disinfectant.It was indicated that the resident sustained burns and had to go to the hospital for 10 days to be treated.
 
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Brand Name
UNKNOWN
Type of Device
BATH, HYDRO-MASSAGE
Manufacturer (Section D)
ARJO HOSPITAL EQUIPMENT AB
verkstadsvagen 5
eslov 24121
SW  24121
MDR Report Key13709115
MDR Text Key287344818
Report Number1419652-2022-00008
Device Sequence Number1
Product Code ILJ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/29/2022
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 NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/29/2022
Distributor Facility Aware Date02/28/2022
Event Location Nursing Home
Date Report to Manufacturer04/29/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/09/2022
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/29/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening;
Patient SexMale
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