MAUDE Adverse Event Report: BAYER HEALTHCARE LLC MICROLET; LANCETS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/06/2014

Event Type  Injury  

Manufacturer Narrative

The product information was not provided.The manufacture date could not be determined and lancets/lancing devices are not 510(k) cleared.Initial reporter address and phone number were not provided.

Event Description

The advocate accidentally stuck her finger with the microlet2 when testing her mother's blood glucose on the breeze2 meter.The product information was not provided.No product is expected to be returned for evaluation.

• Brand Name: MICROLET
• Type of Device: 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 w. beiger st.; mishawaka, IN 46544 ; 5742563441
• MDR Report Key: 4122643
• MDR Text Key: 19371938
• Report Number: 1826988-2014-00335
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2014
• Initial Date FDA Received: 09/26/2014
• 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 Number: 1