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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONTACT¿DETACH; CONTACT DETACH G29 60/6
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CONTACT¿DETACH; CONTACT DETACH G29 60/6 Back to Search Results
Lot Number 5139980
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Hyperglycemia (1905)
Type of Reportable Event Malfunction
Event or Problem Description
(b)(4).Event occurred in the united states.The patient reported that the infusion set's tubing broke as it got snagged while walking around earlier on the day of this report.The blood glucose was reported as 390 mg/dl and the patient self-treated with manual injection.No further information available.
 
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Brand Name
CONTACT¿DETACH
Common Device Name
CONTACT DETACH G29 60/6
MDR Report Key8458929
Report Number3003442380-2019-00782
Device Sequence Number14206784
Product Code FPA
UDI-Device Identifier05705244003293
UDI-Public05705244003293
Combination Product (Y/N)N
PMA/510(K) Number
K041545
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
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
Operator of Device No Information
Device Lot Number5139980
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/07/2016
Initial Report FDA Received Date03/28/2019
Patient Sequence Number1
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