MAUDE Adverse Event Report: TELA BIO, INC. OVITEX PRS REINFORCED TISSUE MATRIX; SURGICAL MESH

Model Number	R20243-1122P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fluid Discharge (2686)
Type of Reportable Event	Serious Injury
Event or Problem Description
A surgeon reported that after a bilateral prepectoral single stage breast reconstruction with ovitex prs pp and adm (acellular dermal matrix) that ovitex prs extruded out of the incision 3 weeks post-op (with drains removed 8 days post op).The devices on this side were replaced with an adm.A review of the surgeon's post suggests the following clinical course.Bilateral direct to implant breast reconstruction was performed with 600cc breast implants and ovitex prs used in the lower pole and adm in the upper.Drains were pulled approximately 8 days after surgery when 20cc/day of fluid was removed.Fluid began necessitating out of the wound on one side approximately 2 weeks later.The surgeon removed the material and replaced with an adm.It is unknown whether the breast implant was also replaced.
Additional Manufacturer Narrative
All clinical information to date has been gathered from the external initial reporter.Internal investigation into potential lots utilized in this procedure show no non-conformances or anomalies that may have caused or contributed to this event.Based on information received to date, there is no evidence showing an association between the adverse event and the use of the device.

• Brand Name: OVITEX PRS REINFORCED TISSUE MATRIX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): TELA BIO, INC.; 1 great valley parkway; suite 24; malvern PA 19355
• Manufacturer (Section G): TELA BIO, INC.; 1 great valley parkway; suite 24; malvern PA 19355
• Manufacturer Contact: gina nagvajara ; 1 great valley parkway; suite 24; malvern, PA 19355
• MDR Report Key: 17625338
• Report Number: 3010513348-2023-00007
• Device Sequence Number: 17988498
• Product Code: FTM
• UDI-Device Identifier: 00856072005142
• UDI-Public: 00856072005142
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K183398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/25/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: R20243-1122P
• Device Catalogue Number: R20243-1122P
• 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: 08/03/2023
• Initial Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: BREAST IMPLANTS AND ADM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female