MAUDE Adverse Event Report: TELA BIO OVITEX PRS REINFORCED TISSUE MATRIX; 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	09/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent two-stage bilateral breast reconstruction with tissue expanders and ovitex prs pga on approximately (b)(6) 2023.It was reported that on (b)(6) 2023 the ovitex prs devices had possibly broken down and extruded through the patient's incisions.The devices were removed to the extent possible, tissue expanders left in place, and reconstruction course continued.
Additional Manufacturer Narrative
The surgeon reported that the patient had thin mastectomy flaps and potentially poor post-operative management which may have contributed to this event.Although an additional surgery was necessary, there was no reconstructive failure as the tissue expanders remained in place.A batch record review showed no non-conformances or anomalies that may have caused or contributed to this event.

• Brand Name: OVITEX PRS REINFORCED TISSUE MATRIX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): TELA BIO; 1 great valley parkway; suite 24; malvern PA 19355
• Manufacturer (Section G): 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: 17961040
• Report Number: 3010513348-2023-00010
• Device Sequence Number: 7007108
• Product Code: FTM
• UDI-Device Identifier: 00856072005012
• UDI-Public: 00856072005012
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2023

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: 09/21/2023
• Initial Report FDA Received Date: 10/18/2023
• 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 (X2)
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female