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 Codes	Wound Dehiscence (1154); Fluid Discharge (2686)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A batch record review showed no non-conformances or anomalies that may have caused or contributed to this event.Wound dehisence and additional surgery are known complications following plastic and reconstructive procedures and are included in the instructions for use as potential complications.It cannot be determined whether the device caused or contributed to this event.
Event or Problem Description
A patient underwent bilateral prepectoral breast reconstruction with ovitex prs and tissue expanders.It was reported that the patient progressed normally for a couple of weeks and drains were pulled.Discoloration appeared around incisions and incisions opened with fluid discharge.One wound was reported to have dehisced and all devices were removed on both sides.This is one of two reports for the same patient for this issue.

• 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: 18059303
• Report Number: 3010513348-2023-00012
• Device Sequence Number: 15386043
• 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
• 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: 12/31/2023
• Device Model Number: R20152-2020G
• Device Catalogue Number: R20152-2020G
• Device Lot Number: ERT-23A01
• 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: 11/02/2023
• 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 IMPLANTED CONCOMITANTLY
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female