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

MAUDE Adverse Event Report: DEXCOM DEXCOM G5 SENSOR

  • 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
 

DEXCOM DEXCOM G5 SENSOR Back to Search Results
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/23/2016
Event Type  Injury  
Event Description
Dexcom g5 sensor upon insertion broke off into child's abdominal wall. Upon removal no wire was seen. A medical emergency prompted scans to be taken of child's abdomen where a wire was found lodged into child's abdominal wall muscle. The wire has split in two pieces and required surgery to remove.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDEXCOM G5 SENSOR
Type of DeviceDEXCOM G5 SENSOR
Manufacturer (Section D)
DEXCOM
MDR Report Key6308194
MDR Text Key66806181
Report NumberMW5067716
Device Sequence Number1
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 02/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/03/2017 Patient Sequence Number: 1
-
-