SKINPEN PRECISION

Description of Event or Problem

A USER OF A SKINPEN PRECISION REPORTED HAVING ANAPHYLACTIC REACTIONS FOLLOWING MICRONEEDLING TREATMENTS. THE USER REPORTED CONDUCTING 2 MICRONEEDLING TREATMENTS ON HERSELF WITH A REACTION OCCURRING AFTER EACH TREATMENT. THE USER REPORTED REQUIRING THE USE OF AN EPI PEN, MEDICATIONS, AND STERIODS AS WELL AS THE NEED FOR AN AMBULANCE FOR EACH REACTION. THE USER REPORTED PERFORMING THE FIRST MICRONEEDLING TREATMENT ON HERSELF USING NUMBING CREAM PRIOR TO THE TREATMENT AND USING PROTEIN RICH PLATELETS (PRP) AS PART OF THE TREATMENT, WHICH IS AN OFF-LABEL USE FOR THE DEVICE. FOR THE SECOND TREATMENT, THE USER REPORTED PERFORMING THE MICRONEEDLING TREATMENT WITHOUT EITHER THE NUMBING CREAM OR THE PRP, AND THAT THE REACTION WAS WORSE FOLLOWING THE SECOND TREATMENT. THE USER'S AGE, BIRTHDATE, WEIGHT, ETHNICITY AND RACE WERE NOT REPORTED TO THE MANUFACTURER. THIS INFORMATION WAS REQUESTED FROM THE USER, HOWEVER, IT WAS NOT PROVIDED.

Additional Manufacturer Narrative

A CLINICIAN CONTACTED THE MANUFACTURER REGARDING A POTENTIAL REACTION TO A MICRONEEDLING PROCEDURE. THE CLINICIAN PERFORMED 2 MICRONEEDLING TREATMENTS ON HERSELF AND EXPERIENCED A REACTION AFTER EACH TREATMENT. DURING THE FIRST TREATMENT, THE CLINICIAN REPORTED THAT SHE APPLIED A NUMBING CREAM AND THEN USED PLATELET RICH PLASMA (PRP) AS PART OF THE TREATMENT. USE OF PRP WITH MICRONEEDLING IS AN OFF-LABEL USE. THE CLINICIAN REPORTED EXPERIENCING A REACTION ABOUT 10 MINUTES AFTER THE TREATMENT. THE CLINICIAN PERFORMED THE MICRONEEDLING TREATMENT ON HERSELF A SECOND TIME, WITHOUT USING PRP AND NUMBING CREAM. THE CLINICIAN REPORTED THAT SHE EXPERIENCED A REACTION ABOUT 15 MINUTES AFTER THE SECOND TREATMENT. NO PHOTOS OF THE AFFECTED AREA(S) OF THE CLINICIAN WERE PROVIDED FOR EXAMINATION. THE CLINICIAN REPORTED THAT SHE "KIND OF HAD SKIN SENSITIVITY," BUT DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING MEDICAL HISTORY. THE CLINICIAN REPORTED THAT SHE NEEDED AN EPI PEN, STERIODS, MEDS AND AN AMBULANCE AFTER EACH ALLEGED REACTION, BUT DID NOT PROVIDE ANY ADDITIONAL HISTORY REGARDING POST-EVENT TREATMENTS. ADDITIONAL INFORMATION REGARDING THE SKINPEN PRECISION DEVICE AND TREATMENT KIT WAS REQUESTED FROM THE CLINICIAN, HOWEVER, IT WAS NOT PROVIDED. NEITHER THE DEVICE NOR THE MICRONEEDLING CARTRIDGES INVOLVED IN THE ALLEGED EVENTS WERE RETURNED TO CROWN AESTHETICS FOR EVALUATION. THE CLINICIAN DID NOT PROVIDE ANY LOT NUMBER OR TRACEABILITY INFORMATION REGARDING THE MICRONEEDLING DEVICE OR THE TREATMENT KIT(S) INVOLVED IN THE EVENT. AS THE REPORTED INCIDENT INDICATES THAT THERE MIGHT HAVE BEEN AN ALLERGIC REACTION TO THE MICRONEEDLES CONTAINED IN THE MICRONEEDLING CARTRIDGE, THE POTENTIAL CARTRIDGES USED IN THE EVENT WERE INVESTIGATED. BASED ON PURCHASING HISTORY FOR THE CUSTOMER, CROWN WAS ABLE TO OBTAIN LOT NUMBERS FOR CARTRIDGES CONTAINED IN TREATMENT KITS THAT HAD BEEN SHIPPED TO THE CUSTOMER. ONLY 2 SEPARATE CARTRIDGE LOT NUMBERS HAD BEEN SHIPPED TO THE CUSTOMER; CARTRIDGE LOT NUMBERS: 22F23N AND 22G18N. BOTH CARTRIDGE LOTS WERE MANUFACTURED ON 7/26/2022. BATCH RECORDS FOR EACH OF THESE CARTLIDGE LOTS WERE REVIEWED WITH NO DISCREPANCIES NOTED. CUSTOMER COMPLAINT RECORDS FOR EACH OF THESE LOTS WERE REVIEWED WITH NO REPORTS OF ADVERSE EVENTS FOR EITHER LOT AND NO COMPLAINTS WHICH INDICATED THERE WAS ANY TYPE OF ISSUE WITH THE MICRONEEDLES. HOWEVER, THERE IS NO WAY TO DETERMINE IF THE CARTRIDGES USED IN THE REPORTED EVENTS WERE FROM EITHER OF THESE LOTS. MOST LIKELY, THE REPORTED ISSUES WERE DUE TO A SENSITIVITY TO THE MICRONEEDLE MATERIAL. THE MICRONEEDLES ARE MADE FROM STAINLESS STEEL AND STAINLESS STEEL IS AN ALLOY WHICH CONTAINS NICKEL. AS PER THE DEVICE LABELING, THE SKINPEN PRECISION SHOULD NOT BE USED BY INDIVIDUALS WHO HAVE AN ALLERGY TO STAINLESS STEEL. AS THE CLINICIAN REPORTED THAT SHE HAD SKIN SENSITIVITY, AND SHE REPORTED THAT THE SECOND EVENT OCCURRED AFTER SHE PERFORMED THE MICRONEEDLING TREATMENT ON HERSELF WITH NO NUMBING CREAM OR OTHER TOPICALS, SHE MAY HAVE EXPERIENCED AN ALLERGIC REACTION TO THE MICRONEEDLES. AS PER THE INSTRUCTIONS FOR USE FOR THE DEVICE, THE SKINPEN SHOULD ONLY BE USED UNDER MEDICAL SUPERVISION, AND THE USER SHOULD BE ACQUAINTED WITH THE OPERATING PROCEDURES FOR THE TREATMENT AS WELL AS THE INDICATIONS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS.