MAUDE Adverse Event Report: OWEN MUMFORD LTD UNISTIK 2 EXTRA; SAFETY LANCET

Model Number AT 0714

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Distress (2329); Discomfort (2330)

Event Date 10/14/2014

Event Type  Other  

Event Description

Complaint reported to owen mumford on (b)(6) 2014: (b)(6) reported that a donor suffered an infection in her finger after it was pricked with a unistik 2 lancet.First lancet used did not appear to puncture skin.Second lancet used and sample was taken from a different finger than 1st attempt.On (b)(6) 2014, donor's father called to say his daughter's finger was red & swollen and that the school nurse referred her to immediate care, where a piece of lancet was reported to have been removed.An antibiotic was given to the donor.Mfr ref#: 8021764-2014-00004.

• Brand Name: UNISTIK 2 EXTRA
• Type of Device: SAFETY LANCET
• Manufacturer (Section D): OWEN MUMFORD LTD; brook hill; woodstock,oxfordshire OX20 1TU; UK OX20 1TU
• Manufacturer (Section G): OWEN MUMFORD USA, INC.; 1755-a west oak commons ct.; marietta GA 30062
• Manufacturer Contact: 1755-a west oak commons ct.; marietta, GA 30062
• MDR Report Key: 4356249
• MDR Text Key: 5172740
• Report Number: 1058602-2014-00004
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Model Number: AT 0714
• Device Lot Number: J4282
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/03/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/20/2014
• Distributor Facility Aware Date: 10/28/2014
• Device Age: 3 MO
• Event Location: Other
• Date Report to Manufacturer: 10/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17 YR
• Patient Weight: 68