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

Model Number	PX2X783090A16MB
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Discomfort (2330); Nodule (4551)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Hcp reported that the patient had pdo threads implanted on (b)(6) 2024.On 04/22/2024, according to the hcp, patient came in for a follow-up 10 days post procedure with bunching under the patient's right eye, near the nose.Patient did not report any pain at the time, but felt some pinching from time to time.Hcp decided to leave the thread inside the patient and to massage it until not visible, as it was not affecting the patient.On (b)(6) 2024, hcp reported that the patient presented with more bunching near the right side of the nose under the eye.Patient felt "poking" and sometimes pain.Hcp felt a thread going past the patient's orbital rim, into the eye socket.Hcp removed the thread.On 06/12/2024, hcp reported that the patient is doing perfectly fine, and that no additional follow-up is needed.
Event or Problem Description
Hcp reported that the patient had pdo threads implanted on (b)(6) 2024.On (b)(6) 2024, according to the hcp, patient came in for a follow-up 10 days post procedure with bunching under the patient's right eye, near the nose.Patient did not report any pain at the time, but felt some pinching from time to time.Hcp decided to leave the thread inside the patient and to massage it until not visible, as it was not affecting the patient.On (b)(6) 2024, hcp reported that the patient presented with more bunching near the right side of the nose under the eye.Patient felt "poking" and sometimes pain.Hcp felt a thread going past the patient's orbital rim, into the eye socket.Hcp removed the thread.On (b)(6) 2024, hcp reported that the patient is doing perfectly fine, and that no additional follow-up is needed.Update: on (b)(6) 2024, hcp was contacted to provide pictures of the patient and additional information.On (b)(6) 2024, another follow-up with the hcp was conducted to provide pictures of the patient and additional information.Hcp provided the implanted date of (b)(6) 2024.On (b)(6) 2024, hcp provided pictures of the patient.
Additional Manufacturer Narrative
Udi related data quality updates only.The report represents a correction to a previously submitted mdr 3007895168-2024-00011-001 brand name: demediox version or model: px2x783090a16mb.Company name: demetech corporation.Primary di number: (b)(4).Device description: absorbable polydioxanone surgical suture fda premarket submission number: k082097.
Event or Problem Description
Hcp reported that the patient had pdo threads implanted on (b)(6) 2024.On (b)(6) 2024, according to the hcp, patient came in for a follow-up 10 days post procedure with bunching under the patient's right eye, near the nose.Patient did not report any pain at the time, but felt some pinching from time to time.Hcp decided to leave the thread inside the patient and to massage it until not visible, as it was not affecting the patient.On (b)(6) 2024, hcp reported that the patient presented with more bunching near the right side of the nose under the eye.Patient felt "poking" and sometimes pain.Hcp felt a thread going past the patient's orbital rim, into the eye socket.Hcp removed the thread.On 06/12/2024, hcp reported that the patient is doing perfectly fine, and that no additional follow-up is needed.Update: on 06/18/2024, hcp was contacted to provide pictures of the patient and additional information.On 06/26/2024, another follow-up with the hcp was conducted to provide pictures of the patient and additional information.Hcp provided the implanted date of (b)(6) 2024.On (b)(6) 2024, hcp provided pictures 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: 19563720
• Report Number: 3007895168-2024-00011
• Device Sequence Number: 3970065
• Product Code: NEW
• UDI-Device Identifier: 10652927777489
• UDI-Public: 10652927777489
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K082097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2024

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: 06/01/2025
• Device Model Number: PX2X783090A16MB
• Device Lot Number: L107-22
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 06/10/2024; 06/10/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/10/2024; 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2022
• 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: Required Intervention
• Patient Sex: Female