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: PRIMUS MEDICAL, LLC PRIME CARE TRANSCNED ADVANCED MATTRESS
  • 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
 

PRIMUS MEDICAL, LLC PRIME CARE TRANSCNED ADVANCED MATTRESS Back to Search Results
Model Number TACM3580
Device Problem Delamination (2904)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/12/2014
Event Type  malfunction  
Manufacturer Narrative
Upon inspection of this mattress, the urethane cover bubbled at the center of the mattress cover but did not peel away exposing the foam of the mattress.This mattress has been isolated in the non-conforming room until investigation is complete and mattress has been dispositioned.A new mattress was delivered to the facility on (b)(4) 2014.This problem has been assigned to capa (b)(4), and a follow-up report will be submitted upon completion of the corrective action.
 
Event Description
Mattress cover is delaminating.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PRIME CARE TRANSCNED ADVANCED MATTRESS
Manufacturer (Section D)
PRIMUS MEDICAL, LLC
boardman OH
Manufacturer Contact
mark hudson
5850 klockner dr
richmond, VA 23231
8042261155
MDR Report Key3788550
MDR Text Key15878867
Report Number3007538326-2014-00021
Device Sequence Number1
Product Code IKY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberTACM3580
Device Catalogue NumberSP03-TACM3580
Device Lot Number41712
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/13/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received03/12/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-