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

Model Number	P20363-2025G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	10/01/2024
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.Given that approximately six months elapsed between implantation and the event noted, it is unlikely that the ovitex prs device caused or contributed to the event.As there was no other direct clinical explanation reported by the surgeon, this event is being reported in an abundance of caution.
Event or Problem Description
A patient underwent bilateral prepectoral direct to implant breast reconstruction with ovitex prs ltr and breast implants on (b)(6) 2024.The left breast implant was removed on (b)(6) 2024 after presenting with drainage from the incision site.The right side was unaffected.

• Brand Name: OVITEX PRS
• 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: 20757148
• Report Number: 3010513348-2024-00021
• Device Sequence Number: 18514927
• Product Code: FTM
• UDI-Device Identifier: 00810055070442
• UDI-Public: 00810055070442
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K214070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 11/22/2024

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: 12/31/2024
• Device Model Number: P20363-2025G
• Device Catalogue Number: P20363-2025G
• Device Lot Number: ERT-24A14
• 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: 10/29/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Female