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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE OZO

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MEDTRONIC MINIMED SENSOR ENLITE OZO Back to Search Results
Model Number MMT-7008A
Device Problem Insufficient Information (3190)
Patient Problem Bacterial Infection (1735)
Event Date 02/11/2015
Event Type  Injury  
Event Description

It was reported that the customer's sensor site got infected. The infection occurred on the second week of having the insulin pump. The sensor site had staphylococcus. Her blood glucose level was not reported. The product was not returned. Nothing further to report.

 
Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.

 
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Brand NameSENSOR ENLITE
Type of DeviceOZO
Manufacturer (Section D)
MEDTRONIC MINIMED
18000 devonshire street
northridge CA 91325
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire street
northridge CA 91325 121
Manufacturer Contact
christopher tupper
18000 devonshire street
northridge, CA 91325-1219
8185764313
MDR Report Key4528546
MDR Text Key16862597
Report Number2032227-2015-07224
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
PMA/PMN Number120010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation PATIENT
Type of Report Initial
Report Date 02/11/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/19/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-7008A
Device Catalogue NumberMMT-7008A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received02/11/2015
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 Unkown

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