SKINPEN PRECISION

Additional Manufacturer Narrative

INFORMATION REGARDING SERIAL NUMBER AND UDI OF THE DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT PROVIDED, DESPITE REQUESTS FOR ADDITIONAL INFORMATION FROM THE MANUFACTURER. THE REPORTER DID NOT INDICATE THAT THERE WERE ANY ISSUES WITH THE DEVICE DURING THE TREATMENT. AS PER THE CONTRAINDICATIONS INCLUDED IN THE SKINPEN PRECISION USER MANUAL AND INSTRUCTIONS FOR USE, MICRONEEDLING TREATMENTS SHOULD NOT BE PROVIDED WHEN THERE IS AN ACTIVE LESION, IRRITATED SKIN AND/OR A SORE OR ULCER. THE PATIENT HAD A PREEXISTING CYST, AND MICRONEEDLING WAS PERFORMED DESPITE DOCUMENTED PRECAUTIONS TO NOT PERFORM THE TREATMENT.

Description of Event or Problem

PATIEN WAS GIVEN A MICRONEEDLING TREATMENT. THE PATIENT HAD A 1X1 CM CYST PRESENT ON HER NECK PRIOR TO THE TREATMENT. THE CLINICIAN REPORTED TO THE IMPORTER/DISTRIBUTOR REPRESENTATIVE THAT MICRONEEDLING WAS NOT PERFORMED DIRECTLY OVER THE CYST. PER THE IMPORTER/DISTRIBUTOR REPRESENTATIVE, THE CLINICIAN REPORTED THAT AN AREA ABOUT 2 CM IN CIRCUMFERENCE AROUND THE CYST WAS LEFT UNTREATED DURING THE MICRONEEDLING SESSION. TWO DAYS FOLLOWING THE SESSION, THE CYST BECAME INFLAMED AND 2 DAYS AFTER THE CYST BECAME INFLAMED, THE PATIENT WAS GIVEN ANTIBIOTICS FOR THE CYST. ONE WEEK LATER, THE CYST HAD TO BE LANCED. THE DATE OF THE TREATMENT WAS NOT PROVIDED BY THE CLINICIAN AND/OR THE DISTRIBUTOR, BUT BASED ON THE SEQUENCE OF EVENTS PROVIDED, THE MICRONEEDLING TREATMENT MAY HAVE BEEN PROVIDED IN EARLY (B)(6) 2023. NO DETAILS REGARDING THE PATIENT, SUCH AS AGE, WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE HEALTHCARE PROVIDER VIA THE IMPORTER/DISTRIBUTOR, BUT WAS NOT PROVIDED. THERE WAS NO REPORTED DEFECT OR MALFUNCTION OF THE SKINPEN PRECISION.