MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3341109
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent primary breast reconstruction surgery with 270cc mentor memoryshape breast implant on both sides and experienced generalized illness symptoms including brain fog, ears ringing, vision problems, dental problems, swollen lymph nodes, infection, breathing issues, pain, anxiety, leaky gut, nausea, increased sensitivities, seizure, swollen legs, weakness, weight loss, and trouble sleeping.No indication of wound infection as patient reports the infection is in a node/nodule near her armpit.She reported that she did have a bike accident but the trauma was to the bone between her shoulder and elbow which required surgery and was told her implants were intact.Patient also reported that the fluid in her chest where her implants are located has been treated and continues to be treated with thoracentesis (surgical intervention).At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch report is for the patient¿s left-sided device.
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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.Reason for device explant and/or reoperation: as of now there is no information regarding the explant or reoperation.(b)(4).Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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.Reason for device explant and/or reoperation: as of now there is no information regarding the explant or reoperation.(b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent primary breast reconstruction surgery with 270cc mentor memoryshape breast implant on both sides and experienced generalized illness symptoms including brain fog, ears ringing, vision problems, dental problems, swollen lymph nodes, infection, breathing issues, pain, anxiety, leaky gut, nausea, increased sensitivities, seizure, swollen legs, weakness, weight loss, and trouble sleeping.No indication of wound infection as patient reports the infection is in a node/nodule near her armpit.She reported that she did have a bike accident but the trauma was to the bone between her shoulder and elbow which required surgery and was told her implants were intact.Patient also reported that the fluid in her chest where her implants are located has been treated and continues to be treated with thoracentesis (surgical intervention).At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch report is for the patient¿s left-sided device.

• Brand Name: MENTOR MEMORYSHAPE BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• 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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 13127937
• Report Number: 1645337-2021-14434
• Device Sequence Number: 1867668
• Product Code: FTR
• UDI-Device Identifier: 00081317005056
• UDI-Public: 00081317005056
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/07/2021
• Device Model Number: 3341109
• Device Catalogue Number: 3341109
• Device Lot Number: 7302262
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 12/31/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2016
• 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: 56 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White