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

Model Number R20152-2020G

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fluid Discharge (2686)

Event Date 10/05/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 331283151
• Report Number: 3010513348-2023-00011
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TISSUE EXPANDERS CONCOMITTANTLY IMPLANTED
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female