MAUDE Adverse Event Report: LANCETS

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

Patient Problems Pain (1994); Swelling (2091)

Event Date 02/01/2017

Event Type  Injury  

Event Description

Used lancets and swelling now occurs intermittently in whole hand and pain in arm.Will speak to doctor.(b)(4).

• Brand Name: LANCETS
• Type of Device: LANCETS
• MDR Report Key: 6352645
• MDR Text Key: 68221305
• Report Number: MW5068042
• Device Sequence Number: 1
• Product Code: FMK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2017

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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: SEVERAL
• Patient Outcome(s): Disability
• Patient Age: 60 YR
• Patient Weight: 117