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: BELMONT MEDICAL TECHNOLOGIES ALLON 2001; THERMAL REGULATING SYSTEM
  • 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
 

BELMONT MEDICAL TECHNOLOGIES ALLON 2001; THERMAL REGULATING SYSTEM Back to Search Results
Catalog Number 100-00001
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Date 08/29/2019
Event Type  malfunction  
Manufacturer Narrative
The allon has not been returned for investigation.It was reported that there was no clinilogger attached.(b)(4) has reached out to the user facility to request as much information as possible surrounding the incident.The investigation is ongoing.Without additional information, it is difficult to determine what occurred in this case.Should additional information become available, a supplemental report will be submitted.
 
Event Description
The user facility reported that a patient was burned while using the allon during a case.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ALLON 2001
Type of Device
THERMAL REGULATING SYSTEM
Manufacturer (Section D)
BELMONT MEDICAL TECHNOLOGIES
780 boston road
billerica MA 01821
Manufacturer (Section G)
BELMONT MEDICAL TECHNOLOGIES
780 boston road
billerica MA 01821
Manufacturer Contact
sabrina belladue
780 boston road
billerica, MA 01821
9783307637
MDR Report Key9131456
MDR Text Key193374408
Report Number1219702-2019-00067
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K024128
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 09/27/2019
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 Health Professional
Device Catalogue Number100-00001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/29/2019
Initial Date FDA Received09/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-