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

Model Number	PX2X46800100A16B
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Nodule (4551)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, the hcp reported that pdo threads were implanted in two patients and both patients experienced buckling.On (b)(6) 2024, medical advice was provided to the hcp by the medical director.On october 28th, the sales representative was contacted to gather information and status of the patients which they were unable to provide.On november 01, 2024, hcp was contacted and provided information regarding the two patients involved.According to the hcp, the first patient is no longer in contact with the hcp and the second patient had threads removed and a scheduled follow-up appointment.Hcp was not cooperating with answering further questions.On november 12th, 2024, a follow-up email was sent to the sales representative to assist in gathering additional information.On november 19th, the sales representative manager was contacted to assist in getting additional information for the case.On december 5th, a phone call was made to the sales representative with no answer.On december 6th, the sales representative returned the call and informed that the information was relayed to the hcp to gather the additional information.According to the sales representative, the hcp did not follow-up with providing additional information.The case has been confirmed to be closed as the hcp is not cooperating with providing the necessary information.

• 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: 20925424
• Report Number: 3007895168-2024-00021
• Device Sequence Number: 5293688
• Product Code: NEW
• UDI-Device Identifier: 10652927697879
• UDI-Public: 10652927697879
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K082097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/04/2024

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: 09/01/2026
• Device Model Number: PX2X46800100A16B
• Device Lot Number: S407-23
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 12/13/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown