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

Model Number	R20143-2020P
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	09/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent bilateral breast reconstruction with tissue expanders and ovitex prs permanent on (b)(6) 2022.The patient experienced abnormal drain output and returned to the operating room on (b)(6) 2022.The remaining ovitex prs material and the implanted tissue expanders were removed on this date.The surgeon placed antibiotic beads to treat any potential infection.
Additional Manufacturer Narrative
All clinical information was relayed by the surgeon to a tela bio representative.The root cause of this event cannot be determined.A batch record review showed that the device met all release specifications and no other anomalies were detected.

• 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: 15512601
• Report Number: 3010513348-2022-00010
• Device Sequence Number: 14745193
• Product Code: FTM
• UDI-Device Identifier: 00856072005074
• UDI-Public: 00856072005074
• 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: 2022
• Device Explanted Year: 2022
• 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): 09/29/2022

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: 07/31/2024
• Device Model Number: R20143-2020P
• Device Catalogue Number: R20143-2020P
• Device Lot Number: ERT-21H13
• 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: 09/16/2022
• Initial Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• 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: 44 YR
• Patient Sex: Female