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

Model Number	R20143-1620P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the associated batch record showed no non-conformances or anomalies that may have caused or contributed to this event.Post-operative infections are common adverse events after implant based breast reconstruction with or without the use of surgical mesh.The ovitex prs device is terminally sterilized and thus is unlikely to cause infection.Further, infection symptoms continued after device removal and apparent replacement of the left breast implant.However, as root cause of the continued infection cannot be confirmed, this event is being conservatively reported in an abundance of caution.
Event or Problem Description
A patient self reported ongoing left breast infection after bilateral implant based breast reconstruction with ovitex prs permanent.It was reported that an infection developed after the original surgery which resulted in the removal of the implant and ovitex prs device.The patient reported ongoing infection in the left breast and "issues in the left implant" even after the removal of these original devices.The patient also experienced redness and heat on the affected breast.They also noted a lack of energy, sporadic fevers, and general malaise.No resolution was noted in the report.

• Brand Name: OVITEX PRS
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): TELA BIO; 1 great valley parkway; suite 24; malvern PA 19355
• Manufacturer Contact: john urtz ; 1 great valley parkway; suite 24; malvern, PA 19355 ; 4843232884
• MDR Report Key: 19930628
• Report Number: 3010513348-2024-00015
• Device Sequence Number: 14143232
• Product Code: FTM
• UDI-Device Identifier: 09421905067706
• UDI-Public: 09421905067706
• Combination Product (Y/N): N
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2024

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: 08/31/2024
• Device Model Number: R20143-1620P
• Device Catalogue Number: R20143-1620P
• Device Lot Number: ERT-21I02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2021
• 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: Required Intervention; Other; Hospitalization
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White