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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC. MDS

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DEXCOM, INC. MDS Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Concussion (2192)
Event Date 05/23/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient's mother contacted dexcom on (b)(6) 2016 to report that the patient experienced an adverse event on (b)(6) 2016. The patient hit his head on a diving board over the weekend and suffered a concussion. It is unknown if the patient was wearing the continuous glucose monitor (cgm) system at the time of the event. There was no alleged device malfunction. No additional event or patient information was provided.
 
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Brand NameNI
Type of DeviceMDS
Manufacturer (Section D)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer (Section G)
DEXCOM, INC.
6340 sequence drive
san diego CA 92121
Manufacturer Contact
kipp durbin
6340 sequence drive
san diego, CA 92121
8582000200
MDR Report Key5734052
MDR Text Key47697494
Report Number3004753838-2016-03535
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P120005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 05/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/17/2016 Patient Sequence Number: 1
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