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

Model Number	R20152-2020G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	10/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The surgeon reported that the patient had relatively thin skin flaps after mastectomy which may have contributed to a lack of well vascularized tissue in the area which may have caused or contributed to this event.A batch record review showed no non-conformances or anomalies that may have caused or contributed to this event.Note to fda reviewer: the date of submission of this file does not match date of report as it was noted that the initial transmission of this mdr failed in the esubmission gateway.This file is being re-sent to ensure it appears in the database as appropriate.
Event or Problem Description
A patient underwent unilateral delayed prepectoral breast reconstruction with ovitex prs pga and a tissue expander on (b)(6) 23.Approximately 3 weeks after the original surgery fibrinous exudate was noted in the pocket.The device was adherent and intact along the perimeter and posterior but not present anteriorly.The devices were explanted on (b)(6) 2023.

• 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 ; 4843202884
• MDR Report Key: 18388824
• Report Number: 3010513348-2023-00011
• Device Sequence Number: 2772876
• Product Code: FTM
• UDI-Device Identifier: 00856072005012
• UDI-Public: 00856072005012
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K183398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2023

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: 09/30/2023
• Device Model Number: R20152-2020G
• Device Catalogue Number: R20152-2020G
• Device Lot Number: ERT-22J05
• 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: 10/05/2023
• Initial Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TISSUE EXPANDERS CONCOMITTANTLY IMPLANTED
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female