inforMED
InjuryGAX

TOURNIQUET, ORANGE, 1"X18", FLAT

Received Oct 31, 2023 · Event occurred Oct 4, 2023

Report 1417592-2023-00432 · MDR key 18038467

Device

Generic name

Tourniquet, Orange, 1"x18", Flat

Catalog number

DYND75020OFCS

Product problems

  • Appropriate Device Problem Term/Code Not Available
  • Appropriate Device Problem Term/Code Not Available

Patient

Unknown

  • Blister
  • Skin Inflammation/ Irritation
  • Blister
  • Skin Inflammation/ Irritation

Narrative

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, THERE WERE SEVERAL INCIDENTS WHERE THE TOURNIQUET CAUSED THE SKIN ON THE "TOE" TO HAVE "BLISTERS AND REDNESS". THE CUSTOMER REPORTED THE PATIENTS WOULD NOTIFY THE CUSTOMER "12-24 HOURS" AFTER THE PROCEDURE WHEN THE PROCEDURAL WRAP CAME OFF. THE CUSTOMER REPORTED AS A RESULT OF THE REPORTED INCIDENT THE PATIENTS WERE PRESCRIBED "CLINDAMYCIN 300MG, BACTRIM, AND SILVADENE" AND REQUIRED FOLLOW-UP WITH THE PHYSICIAN. SAMPLE REQUESTED FOR RETURN EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

ACCORDING TO THE CUSTOMER, THERE WERE SEVERAL INCIDENTS WHERE THE TOURNIQUET CAUSED THE SKIN ON THE "TOE" TO HAVE "BLISTERS AND REDNESS".