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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER HEALTHCARE LLC MINILET; BLOOD GLUCOSE LANCETS
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BAYER HEALTHCARE LLC MINILET; BLOOD GLUCOSE LANCETS Back to Search Results
Lot Number 1-O37KC
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Needle Stick/Puncture (2462)
Event Date 03/23/2015
Event Type  Injury  
Event Description
The advocate in the (b)(6) stated a nurse accidentally placed a used minilet lancet in her glucolet2 device.She inadvertently pressed the release button and stuck herself.She followed the facility's protocol.Product was not replaced.
 
Manufacturer Narrative
The model# and expiration date were not provided.The manufacture date was not determined.Lancets/ lancing devices are not 510(k) cleared.In some countries outside the us, customer information is not provided due to privacy laws.Only the initial reporter name and phone# were provided.
 
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Brand Name
MINILET
Type of Device
BLOOD GLUCOSE LANCETS
Manufacturer (Section D)
BAYER HEALTHCARE LLC
430 s. beiger st.
mishawaka IN 46544
Manufacturer (Section G)
BAYER HEALTHCARE LLC
430 s. beiger st.
mishawaka IN 46544
Manufacturer Contact
roger sonnenburg
430 s. beiger st.
mishawaka, IN 46544
5742563441
MDR Report Key4770701
MDR Text Key5780878
Report Number1826988-2015-00209
Device Sequence Number1
Product Code FMK
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 04/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Nurse
Device Lot Number1-O37KC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/23/2015
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 Reuse
Patient Sequence Number1
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