MAUDE Adverse Event Report: PDO MAX PDO MAX THREADS LEVO AND SMUTH; ABSORBABLE POLYDIOXANONE SURGICAL SUTURE

Model Number	PM19100L-FE-BP
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The infection happened after the procedure.Unsure if reaction is from patient's clotting disorder and autoimmune disorder, unsterile procedure or threads themselves.No other issues reported regarding threads from this lot.
Event or Problem Description
During a procedure the patient received levo 19x100mm barbed threads and smuth s 30gx38mm smooth threads.The patient notified the provider on 7/11/22 that she had some swelling, soreness and some discharge after the procedure.The provider also injected prp at the same time as threads.Patient's condition worsened needing hospitalization.Infection progressed to necrotizing fascitis and required 4-day hospitalization stay.The medical director called and spoke with the treating physician and reviewed treatment plan and hospitalization records.It is not believed that infection was caused by the threads themselves but the patient's underlying medical history contributing to the poor outcome.The patient has several medical conditions that are contraindications outlined in the protocols.The protocols were reviewed by the medical director with the treating physician, and they will continue to monitor the patient.

• Brand Name: PDO MAX THREADS LEVO AND SMUTH
• Common Device Name: ABSORBABLE POLYDIOXANONE SURGICAL SUTURE
• Manufacturer (Section D): PDO MAX; 4971 bear road; liverpool NY 13088
• Manufacturer (Section G): PDO MAX; 4971 bear road; liverpool NY 13088
• Manufacturer Contact: juliana koval ; 4971 bear road; liverpool, NY 13088 ; 3153830339
• MDR Report Key: 15113919
• Report Number: 3015289316-2022-00001
• Device Sequence Number: 14939506
• Product Code: NEW
• UDI-Device Identifier: 00850018324304
• UDI-Public: 00850018324304
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K190245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 07/27/2022

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: 12/20/2023
• Device Model Number: PM19100L-FE-BP
• Device Catalogue Number: PM19100L-FE-BP
• Device Lot Number: YR21120182
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2021
• 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: Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White