MAUDE Adverse Event Report: BELLUS MEDICAL, LLC SKINPEN PRECISION MICRONEEDLING SYSTEM; POWERED MICRONEEDLE DEVICE

Model Number	REF 101
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Angioedema (4536)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient with a history of hypothyroidism underwent microneedling and the use of biosomes following the micorneedling treatment.Healthcare provider reported that patient had a sensitivity to augmentin, sintomycin, dalcin and sinophed.One hour following the microneedling and biosome treatment, the patient experienced itching all over the body and an urticarial rash.The patient was examined in the emergency room and was treated with steriods and an iv of telefast.Clinician reported patient's condition resolved.
Additional Manufacturer Narrative
The serial number for the device reported to have been used during the event was provided.Device history records for the skinpen precision serial number (b)(6) were reviewed with no inconsistencies noted.Lot number information for the treatment kit consisting of the microneedling cartridge and lift hydrogel used during the procedure were not provided.Customer complaint trends for this device were reviewed, with no trends of reactions of this type detected.The distributor nor the clinician reported any type of malfunction of or issue with the microneedling device, or the components of the treatment kit used during the procedure.The details regarding the microneedling treatment were provided by the healthcare provider to the manufacturer for review.The clinician reported that the patient was given a microneedling treatment on her face and neck and that 3 passes with the device at a treatment depth that resulted in erythem and slight pinpoint bleeding were performed.The clinician reported applying anesthetic lidocaine 15% prior to the treatment and then used lift hydrogel as a glide during the treatment.The clinician reported applying biosomes (synthetic exosomes) post-treatment.The clinician reported that no topicals were applied prior to the treatment or for 24 to 72 hours following the treatment.One hour after the treatment, the patient the patient developed generalized itching (pruritus), an urticarial rash, and angioedema, but no shortness of breath.She was treated in the emergency room with steroids and an iv of telefast, leading to marked improvement in her condition.The patient did not report prior microneedling treatments or similar reactions.Based on the reported reaction, it is possible that the biosomes, applied post-microneedling, contributed to the observed symptoms of pruritus, urticaria, and angioedema.Topical products not specifically tested for deeper skin penetration may cause reactions, especially when introduced into open channels created by microneedling.As per the device instructions for use, only lift hydrogel should be used during the microneedling treatment and within the first 24 hours post-treatment.The clinician reported that biosomes were applied after the microneedling treatment which may have resulted in the reported event.

• Brand Name: SKINPEN PRECISION MICRONEEDLING SYSTEM
• Common Device Name: POWERED MICRONEEDLE DEVICE
• Manufacturer (Section D): BELLUS MEDICAL, LLC; 207 mockingbird lane; johnson city TN 37604
• Manufacturer (Section G): BELLUS MEDICAL, LLC; 207 mockingbird lane; johnson city TN 37604
• Manufacturer Contact: marie fogartie ; 207 mockingbird lane; johnson city, TN 37604 ; 4236302296
• MDR Report Key: 21322885
• Report Number: 3010392991-2025-00001
• Device Sequence Number: 8192678
• Product Code: QAI
• UDI-Device Identifier: 00863221000330
• UDI-Public: 00863221000330
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: DEN160029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 02/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2025
• Device Model Number: REF 101
• Device Catalogue Number: F5SP004
• Device Lot Number: 62787
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANESTHETIC LIDOCAINE 15%; BIOSOMES (SYNTHETIC EXOSOMES), POST-TREATMEN; LIFT HYDROGEL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female