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 TL500
  • 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 TL500 Back to Search Results
Model Number TL500
Device Problems Break (1069); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/25/2013
Event Type  malfunction  
Event Description
Customer called in and stated that the head deck bolts from their bed broke.
 
Manufacturer Narrative
A review of complaints took place and the firm has concluded that this complaint should have been filed as a mdr.The bed frame had the right and left head deck pivot point bolt shear causing the head section of the bed to detach from the mid-section of the bed frame.During the review of complaints there were similar occurrences that the firm found and have filed mdrs for these complaints as well.The firm is monitoring for any future complaints.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TL500
Manufacturer (Section D)
PRIMUS MEDICAL LLC
boardman OH
Manufacturer Contact
layla morris
8401 southern blvd
boardman, OH 44512
3309659681
MDR Report Key4324797
MDR Text Key5251399
Report Number3007538326-2014-00165
Device Sequence Number1
Product Code FNL
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 12/02/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberTL500
Device Catalogue NumberSP01-TL500RH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/25/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-