Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. VELARIS MATTRESS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
  • 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
 

ARJOHUNTLEIGH POLSKA SP. Z O.O. VELARIS MATTRESS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE Back to Search Results
Device Problem Dent in Material (2526)
Patient Problem Tissue Breakdown (2681)
Event Date 12/11/2023
Event Type  Injury  
Event Description
We have received information from one customer that their patients sustained serious injuries while using an arjo mattress.There are 9 cases of serious skin breakdown, which occurred in different locations of patients bodies.This is report number 1 of 9 that will be submitted.The customer alleged that the mattresses had a dip or there was a sensation of a hard surface.The customer placed the mattresses into circulation and they are still used by the patients.These are mattresses built of foam, which responds to the patient¿s weight and patient¿s are supported on this foam.The investigation into the alleged dip in the center of the mattress is ongoing.This report is fulfilled taking a conservative approach, following the serious injury reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VELARIS MATTRESS
Type of Device
MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
Manufacturer (Section D)
ARJOHUNTLEIGH POLSKA SP. Z O.O.
ul. ks. piotra wawrzyniaka 2
komorniki PL-62 052
PL  PL-62052
MDR Report Key18667478
MDR Text Key334897875
Report Number1419652-2024-00019
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/08/2024
1 Device was Involved in the Event
Date FDA Received02/08/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/08/2024
Distributor Facility Aware Date01/10/2024
Event Location Hospital
Date Report to Manufacturer02/08/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
-
-