MAUDE Adverse Event Report: DEMETECH CORPORATION DEMEDIOX; ABSORBABLE POLYDIOXANONE SURGICAL SUTURE

Model Number	PX2X29800100A16MB
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Nodule (4551)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, hcp reported a pdo thread lift with four threads implanted on (b)(6) 2024.According to the hcp, eleven days later (b)(6) 2024), the patient experienced swelling in the right mucosa.Hcp prescribed augmentin and prednisone to the patient.Hcp stated after 1.5 months, the threads were palpable on the patient's cheek and mucosa, with nodules on the mucosa and a 0.5 cm nodule on the right side of the patient's face.On (b)(6) 2024, hcp provided pictures of before and after the procedure.Hcp stated that seven weeks after the procedure, the lesion appeared and was already doing much better.Buccal mucosa was swollen and bumpy along the course of the thread.According to the hcp, swelling inside of the patient's cheeks and skin never really went away.Hcp requested medical advice from the medical director.On (b)(6) 2024, the medical director was sent the information pertaining to this case to provide medical advice.On (b)(6) 2024, the medical director provided medical advice to the hcp which the medical director stated: "appears to be a granuloma - if they felt the thread inside the buccal mucosa it was probably too deep / too close to the oral cavity and may have caused the infection/granuloma.I would have them treat this like any other granuloma based on their medical director's assessment/judgment.In my practice, i treat granulomas with oral antibiotics and intralesional 5-fu and diluted triamcinolone (k-5) and repeat after 4-6 weeks as needed." the hcp requested to have someone call her as there have been a few developments with the patient.According to the hcp, there is a puss at stenson's duct, and the hcp has the patient on clindamycin.On (b)(6) 2024, the hcp's contact information was provided to the medical director to call the hcp directly.The medical director stated that he left a voicemail with the hcp.On (b)(6) 2024, follow up communication was made to the hcp, which they replied that they did speak with the medical director and the patient was refunded.Patient has not followed up with the hcp.On (b)(6) 2024, another follow-up was made to the hcp to inquire about the status of the patient.On (b)(6) 2024, hcp stated that the patient has not replied to any further communication.The case is closed as the patient has not replied to any communications from the customer and the customer is unable to provide the status of the patient.

• Brand Name: DEMEDIOX
• Common Device Name: ABSORBABLE POLYDIOXANONE SURGICAL SUTURE
• Manufacturer (Section D): DEMETECH CORPORATION; 5980 miami lakes dr; miami lakes FL 33014
• Manufacturer (Section G): ECTODERMA DBA COSMOFRANCE; 2121 sw 3rd ave ste 500; miami FL 33129
• MDR Report Key: 20378221
• Report Number: 3007895168-2024-00015
• Device Sequence Number: 3795671
• Product Code: NEW
• UDI-Device Identifier: 10652927721314
• UDI-Public: 10652927721314
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K082097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 08/19/2024

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: 11/01/2024
• Device Model Number: PX2X29800100A16MB
• Device Lot Number: W278-21
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 10/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AUGMENTIN; CLINDAMYCIN; PREDNISONE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 73 KG