MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND MODERATE PLUS PROFILE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	3502700
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.  as such, the investigation will be closed.  if the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.  this report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.  this report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.  if certain information is unknown, not available or does not apply, the section/field of the form is left blank.Reason for device explant and/or reoperation: defective device, wound infection.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a primary breast reconstruction surgery with 700cc mentor smooth round moderate plus profile saline breast implants.Post-operatively, the patient experienced seepage underneath her left breast incision site.The seepage increased and the patient reported that she was soaking through drainage pads rapidly.The patient was seen by a surgeon and sutures were placed under her left breast to stop the leaking.The day after sutures were placed, the patient woke up with a fever and swelling of the left breast as well as pain in her left arm and shooting pain in her shoulder area.The patient was admitted to a hospital where a sepsis protocol was implemented due to the patient¿s prior history of sepsis.Samples were taken from both breasts and sent to pathology, though the pathology reports were not disclosed to mentor.It was also reported that the patient¿s blood pressure dropped, and her infection was treated with antibiotics.The patient was diagnosed with cellulitis bilaterally.Unspecified scans indicated that defects were also observed on both patient¿s implants.As a result, the patient underwent bilateral removal surgery without implant replacement on (b)(6) 2024.This report is for the left implant.Refer to manufacturing report number 1645337-2024-03841 for the contralateral event.

• Brand Name: MENTOR SMOOTH ROUND MODERATE PLUS PROFILE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 18997142
• Report Number: 1645337-2024-03840
• Device Sequence Number: 20927973
• Product Code: FWM
• UDI-Device Identifier: 00081317001515
• UDI-Public: 00081317001515
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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 Catalogue Number: 3502700
• Device Lot Number: 9938619
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2023
• 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
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White