MAUDE Adverse Event Report: HTL-STREFA S.A. ACTI-LANCE SAFETY LANCET UNIVERSAL 23G

Model Number 23G

Device Problem Material Separation (1562)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Type  malfunction  

Event Description

Lab reports a little difficulty with blood flow after using the lancet, but no pain.Patient then returned two days later, finger was red, swollen, and painful to touch.An x-ray revealed small object in skin of finger used.

• Brand Name: ACTI-LANCE SAFETY LANCET UNIVERSAL 23G
• Type of Device: SAFETY LANCET
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• Manufacturer (Section G): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• Manufacturer Contact: justyna zemigala ; adamowek 7; ozorkow, 95-03-5 ; PL 95-035
• MDR Report Key: 14407069
• MDR Text Key: 300226414
• Report Number: 9613304-2022-00005
• Device Sequence Number: 1
• Product Code: FMK
• UDI-Device Identifier: 05901549097023
• UDI-Public: (01)05901549097023(17)251201(10)A11L866M1
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23G
• Device Catalogue Number: 7156
• Device Lot Number: A11L866M1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male