MAUDE Adverse Event Report: TELA BIO OVITEX PRS (LTR); SURGICAL MESH

Model Number	P20163-2020G
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Codes	Seroma (2069); Fluid Discharge (2686)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A batch record review was conducted which showed no non-conformances or anomalies that may have caused or contributed to this event.The devices were manufactured and sterilized to specification.Seroma is a common complication after implant based breast reconstruction with or without the use of surgical mesh.Discussion with the reporting surgeon revealed no potential causes for this event and the root cause could not be determined.
Event or Problem Description
It was reported that a seroma devloped after bilateral breast reconstruction with ovitex prs ltr and tissue expanders creating drainage through incision sites.A washout was conducted and tissue expanders were replaced.

• Brand Name: OVITEX PRS (LTR)
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): TELA BIO; 1 great valley parkway; suite 24; malvern PA 19355
• Manufacturer Contact: john urtz ; 1 great valley parkway; suite 24; malvern, PA 19355 ; 4843232884
• MDR Report Key: 19982545
• Report Number: 3010513348-2024-00017
• Device Sequence Number: 16828287
• Product Code: FTM
• UDI-Device Identifier: 00810055070275
• UDI-Public: 00810055070275
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K214070
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: P20163-2020G
• Device Catalogue Number: P20163-2020G
• Device Lot Number: ERT-23J02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2023
• 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; Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female