MAUDE Adverse Event Report: HYPOGUARD CORPORATION HYPOGUARD LANCET DEVICE; SINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE

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

Patient Problems Hepatitis (1897); Needle Stick/Puncture (2462)

Event Date 02/28/2012

Event Type  Injury  

Event Description

In accordance with 21 cfr 803.22 (b)(2), we are notifying you that on may 17, 2012, a caller contacted roche diagnostics and reported an event that occurred on (b)(6) 2012.The caller reported a first responder performing a glucose test on an accident victim suffered an accidental stick from a hypoguard lancet device.The first responder was subsequently tested and diagnosed positive for hepatitis c.The hypoguard lancet device mentioned in this event is not manufactured or imported by our firm.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: HYPOGUARD LANCET DEVICE
• Type of Device: SINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE
• Manufacturer (Section D): HYPOGUARD CORPORATION
• MDR Report Key: 17528303
• MDR Text Key: 321130890
• Report Number: MW5135234
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1