• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL GAYMAR MEDI-THERM LLL SYSTEM, THERMAL REGULATING

  • 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
 

STRYKER MEDICAL GAYMAR MEDI-THERM LLL SYSTEM, THERMAL REGULATING Back to Search Results
Model Number MTA6900
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Superficial (First Degree) Burn (2685)
Event Date 11/22/2021
Event Type  Injury  
Event Description
Upon arrival into pacu, patient complained of severe right buttock pain. Upon inspection, area approx. 15 x 15 cm reddened and blanchable with white circular areas surrounding. Operating room staff reported patient was lying on warming blanket during surgery. Pt into operating room at 0725 and out of operating room at 1214. Plastics consulted and pt seen. First-degree thermal burn to bilateral buttocks. Will apply barrier cream twice daily. Should heal without any surgical intervention. Device sequestered. Device sent without patient probe. Biomed received approval to check unit. Ran device at low and high manual modes. Indicated low temperature 4. 0c/actual 4. 2c. Indicated high temperature 42c/actual 42. 3c. No issues found with device and device returned to service. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGAYMAR MEDI-THERM LLL
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
STRYKER MEDICAL
MDR Report Key13019075
MDR Text Key282398484
Report NumberMW5106085
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMTA6900
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/15/2021 Patient Sequence Number: 1
-
-