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:; NONE
  • 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
 

; NONE Back to Search Results
Device Problems Moisture Damage (1405); Naturally Worn (2988)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A problem has been identified where the symbioso mattress cover has worn and fails to prevent fluid from leaking into the mattress body.
 
Manufacturer Narrative
Linet is aware of the potential adverse events that could occur given the continued misuse of the symbioso mattress covers and plans the following actions: share the conclusion of our investigation with the user facility making the complaint and provide the user facility the opportunity to purchase new mattress covers.Provide a reminder to our customers using the mattress covers the importance of following the product cleaning and inspection instructions.This reminder will include the fda's safety communication, "damaged or worn covers for medical bed mattresses pose risk of contamination and pt infection: fda safety communication." provide product feedback into the symbioso mattress cover design to consider including additional cleaning agents and protocols.This info may lead to a future product enhancement as determined by our design controls procedure.No, it was not returned, but we did an eval report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
NONE
MDR Report Key3952943
MDR Text Key4625896
Report Number3008007426-2014-00001
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Unknown
Type of Report Initial
Report Date 07/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Distributor Facility Aware Date07/02/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/10/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Patient Sequence Number1
-
-