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

Model Number	P20263-1020G
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
Additional Manufacturer Narrative
A tela bio medical affairs spoke with the reporting surgeon during the week of july 7th, 2025 and all information reasonably known to tela bio from this communication and all other investigation is included in this report.The surgeon reported four similar cases simultaneously that occurred intermittently over the course of approximately six months and did not offer full case details for each event.A batch record review was conducted which showed no non-conformances or anomalies.The lot met all release specifications and was sterilized utilizing validated sterilization parameters.Wound complications and fluid collection are known risks associated with soft tissue reinforcement procedures.
Event or Problem Description
It was reported that a patient experienced fluid collection and wound drainage approximately one month after a cosmetic revision procedure performed with breast implants and ovitex prs.The surgeon performed a washout to address the drainage issue.

• 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 Contact: john urtz ; 1 great valley parkway; suite 24; malvern, PA 19355 ; 4843202884
• MDR Report Key: 22609630
• Report Number: 3010513348-2025-00010
• Device Sequence Number: 5384408
• Product Code: FTM
• UDI-Device Identifier: 00810055070770
• UDI-Public: 00810055070770
• 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
• 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): 07/25/2025

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 Expiration Date: 01/31/2026
• Device Model Number: P20263-1020G
• Device Catalogue Number: P20263-1020G
• Device Lot Number: ERT-24H15
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MOTIVA BREAST IMPLANTS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female