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 (R) TRANSCEND 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 (R) TRANSCEND 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 08/12/2014
Event Type  malfunction  
Event Description
Customer emailed stating that they had a mattress that delaminated.
 
Manufacturer Narrative
Upon inspection of this mattress the urethane cover bubbled at the left side of the mattress cover but did not expose the foam of the mattress.A new mattress was shipped to the customer on 09/08/2014.This problem was been assigned to capa #(b)(4), and a follow-up report will be submitted upon completion of the corrective action.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PRIME CARE (R) TRANSCEND ADVANCED MATTRESS
Manufacturer (Section D)
PRIMUS MEDICAL LLC
boardman OH
Manufacturer Contact
mark hudson
5850 klockner dr
richmond, VA 23231
8042261155
MDR Report Key4110325
MDR Text Key4833299
Report Number3007538326-2014-00076
Device Sequence Number1
Product Code IKY
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial
Report Date 09/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2014
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 Number061312
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/12/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-