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

Model Number	3501430
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Local Reaction (2035); Paresthesia (4421)
Date of Event	03/13/2021
Type of Reportable Event	Serious Injury
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: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old hispanic female patient, who's undergone primary breast augmentation with two 225cc mentor smooth round spectrum saline breast prostheses, suffered left breast pain, post-procedure.The left breast is described to feel like a hot sharp sword, throbbing, and has heating pad sensation.The patient is unable to move the left breast, lean forward, have physical therapy or lay on the right side of the body due to stabbing pain.Both implants are also reported to be engorged and heavy.The patient went to the emergency room due to the pain.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch form is for the right breast prosthesis.
Additional Manufacturer Narrative
On march 19, 2024, mentor received additional information indicating that the patient's mastitis came back and the patient had to go back to an emergency room.She experienced chest and breast pain.A scan showed high density in her breasts, and she suffered breast pain so bad that it made her vomit.The patient is local to the top of the left breast and felt like hot knives stabbing.She was diagnosed, by the emergency room's doctor with capsule formation, as the implants were also high, hard and have doubled in size.Lastly, she also experienced neck and back pain.

• Brand Name: MENTOR SMOOTH ROUND SPECTRUM
• 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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 11690953
• Report Number: 1645337-2021-04223
• Device Sequence Number: 3096921
• Product Code: FWM
• UDI-Device Identifier: 00081317001973
• UDI-Public: 00081317001973
• 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: 2008
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

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: 05/12/2008
• Device Model Number: 3501430
• Device Catalogue Number: 3501430
• Device Lot Number: 5534646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2004
• 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: Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic