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

Model Number	P20263-0815G
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Fluid collection (e.G.Seroma) and reoperation (additional intervention including surgery) are noted as potential adverse events in the ovitex prs instructions for use.Such events are not uncommon after plastic and reconstructive procedures.A batch record review showed no non-conformances or anomalies that may have caused or contributed to this event.No evidence suggests that the device caused the event noted herein.No information regarding dates of events or specific patient details were received despite repeated requests to the initial reporter's office.
Event or Problem Description
It was reported that a patient experienced unexpected drainage after breast reconstruction utilizing ovitex prs ltr and breast implants.Upon reoperation it was noted that only the polymeric component of the device remained.
Additional Manufacturer Narrative
Fluid collection (e.G.Seroma) and reoperation (additional intervention including surgery) are noted as potential adverse events in the ovitex prs instructions for use.Such events are not uncommon after plastic and reconstructive procedures.A batch record review showed no non-conformances or anomalies that may have caused or contributed to this event.No evidence suggests that the device caused the event noted herein.
Event or Problem Description
It was reported that a patient experienced unexpected drainage after mastopexy utilizing ovitex prs ltr and breast implants.Upon reoperation it was noted that only the polymeric component of the device remained.

• Brand Name: OVITEX PRS
• 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: john urtz ; 1 great valley parkway; suite 24; malvern, PA 19355 ; 4843202884
• MDR Report Key: 24520657
• Report Number: 3010513348-2026-00002
• Device Sequence Number: 8522851
• Product Code: FTM
• UDI-Device Identifier: 00810055070619
• UDI-Public: 00810055070619
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K214070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: 04/30/2026
• Device Model Number: P20263-0815G
• Device Catalogue Number: P20263-0815G
• Device Lot Number: ERT-24K04
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 54 KG