SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE)

Description of Event or Problem

MENTAL HEALTH ISSUES [MENTAL DISORDER] SCARS [SCAR] HYPERSENSITIVE SKIN/ SENSITIVITY [SENSITIVE SKIN] FAT LOSS [FAT TISSUE DECREASED] LARGE PORES/ ENLARGED PORES [DILATED PORES] HYPERPIGMENTATION [SKIN HYPERPIGMENTATION] SKIN PAIN [PAIN OF SKIN]. CASE NARRATIVE: BELGIUM REPORT RECEIVED FROM A CONSUMER ON (B)(6) 2025 REPORTING FOR HERSELF A 35-YEARS-OLD CAUCASIAN FEMALE PATIENT WHO HAD RECEIVED A SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE) TREATMENT ON (B)(6) 2024 FOR HYPERSENSITIVE SKIN, ENLARGED PORES, REDNESS/ROSACEA AND FAT LOSS. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. CONCOMITANT MEDICATIONS AND FOOD SUPPLEMENTS WERE NOT PROVIDED. THE PATIENT WAS NOT ALLERGIC TO ANY DRUG OR FOOD. THE PATIENT HAD NOT RECEIVED TREATMENT WITH OTHER TOXIN PRODUCTS, DERMAL FILLERS, OR COSMETIC PROCEDURES PRIOR TO THE EVENTS. THE PATIENT DID NOT TAKE ANY MEDICATION AND WAS IN PERFECT HEALTH. ON (B)(6) 2024, THE SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE) TREATMENT WAS PERFORMED ON AN UNKNOWN AREA AT THE UNKNOWN DEPTH. LOT AND EXPIRY DATE NOT PROVIDED. ON (B)(6) 2024, THE PATIENT EXPERIENCED MENTAL HEALTH ISSUES, SCARS, HYPERSENSITIVE SKIN, FAT LOSS, LARGE PORES, SKIN HYPERPIGMENTATION AND SKIN PAIN. THE PATIENT REPORTED RECEIVING SKINPEN MICRONEEDLING TWICE AS A TREATMENT FOR THE REPORTED ADVERSE EVENTS. A FOLLOW-UP QUERY WAS ISSUED TO CLARIFY WITH NO RESPONSE RECEIVED. THE PATIENT DID NOT UNDERGO ANY LABORATORY OR DIAGNOSTIC TESTS. PATIENT-REPORTER DESCRIBED THE EVENTS OF SCARS, ENLARGED PORES, SENSITIVITY, AND FAT LOSS AS PERMANENT DAMAGE. AT THE TIME OF REPORT, THE OUTCOME OF THE EVENTS MENTAL DISORDER, SCAR, HYPERSENSITIVE SKIN, FAT TISSUE DECREASED, DILATED PORES, SKIN HYPERPIGMENTATION AND SKIN PAIN WAS NOT RESOLVED. THE INTENSITY OF THE EVENTS MENTAL DISORDER, SCAR, HYPERSENSITIVE SKIN, FAT TISSUE DECREASED, DILATED PORES, SKIN HYPERPIGMENTATION AND SKIN PAIN WAS NOT REPORTED. IT WAS UNKNOWN IF THE SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE) PRODUCT WAS AVAILABLE FOR RETURN. CAUSALITY ASSESSMENT PER REPORTER BETWEEN EVENTS OF MENTAL DISORDER, SCAR, HYPERSENSITIVE SKIN, FAT TISSUE DECREASED, DILATED PORES, SKIN HYPERPIGMENTATION AND SKIN PAIN AND SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE) WAS NOT PROVIDED. HEALTH EFFECT: CLINICAL CODE: E0206, UNSPECIFIED MENTAL, EMOTIONAL OR BEHAVIOURAL PROBLEM MEDDRA PREFERRED TERM: MENTAL DISORDER HEALTH EFFECT: CLINICAL CODE: E1715, SCAR TISSUE. MEDDRA PREFERRED TERM: SCAR. HEALTH EFFECT: CLINICAL CODE: E0402, HYPERSENSITIVITY/ALLERGIC REACTION. MEDDRA PREFERRED TERM: SENSITIVE SKIN. HEALTH EFFECT: CLINICAL CODE: E1717, SKIN DISORDERS. MEDDRA PREFERRED TERM: FAT TISSUE DECREASED. HEALTH EFFECT: CLINICAL CODE: E1717, SKIN DISORDERS. MEDDRA PREFERRED TERM: DILATED PORES. HEALTH EFFECT: CLINICAL CODE: E171602, HYPERPIGMENTATION. MEDDRA PREFERRED TERM: SKIN HYPERPIGMENTATION. HEALTH EFFECT: CLINICAL CODE: E2330, PAIN. MEDDRA PREFERRED TERM: PAIN OF SKIN. THE CLINICIAN WAS CONTACTED ON MULTIPLE OCCASIONS TO REQUEST ADDITIONAL INFORMATION AS WELL AS THE DEVICE AND TREATMENT KIT TRACEABILITY INFORMATION WITH NO RESPONSE RECEIVED. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. COMPANY COMMENT: A 35-YEARS-OLD FEMALE PATIENT UNDERWENT THE SKINPEN PRECISION SYSTEM TREATMENT ON AN UNKNOWN AREA AT UNKNOWN DEPTH. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED SCAR, SENSITIVE SKIN, DECREASED FAT TISSUE, DILATED PORES, SKIN HYPERPIGMENTATION AND SKIN PAIN. IN ADDITION, IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED MENTAL DISORDER. THE PATIENT WAS REPORTEDLY IN GOOD HEALTH PRIOR TO THE TREATMENT AND WAS NOT TAKING ANY MEDICATIONS. NO ALTERNATE MEDICAL, PROCEDURAL, OR PHARMACOLOGICAL EXPLANATIONS FOR THE REPORTED EVENTS HAVE BEEN IDENTIFIED OR REPORTED. GIVEN THE TEMPORAL RELATIONSHIP BETWEEN THE PROCEDURE AND THE ONSET OF THE SYMPTOMS, AND IN THE ABSENCE OF AN ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP TO THE SKINPEN PRECISION SYSTEM TREATMENT CANNOT BE ENTIRELY EXCLUDED AND THUS ASSESSED AS POSSIBLY RELATED. THE COMPANY WILL CONTINUE MONITORING THE BENEFIT-RISK PROFILE FOR THE PRODUCT.

Additional Manufacturer Narrative

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