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

Model Number	3545507
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Local Reaction (2035); Swollen Lymph Nodes/Glands (4432); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2020
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: generalized illness, local reaction, lymphadenopathy, rupture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old caucasian female patient underwent a breast augmentation revision with a mentor memorygel breast implant 550cc and suffered bilateral generalized illness, local reaction, lymphadenopathy, rupture.The patient experienced breast swelling in the left breast and milk production in both breasts, fatigue, dizziness, vertigo, feeling of numbness in arms at times, lymph nodes in groin and left arm are swollen.As a result, the patient had undergone removal and replacement with mentor memorygel breast implant 650cc on (b)(6) 2021.This medwatch is for the right side.
Additional Manufacturer Narrative
On 9/2/2021, a manufacturing record evaluation was performed for the finished device 1010996 number, and no non-conformances were identified.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2021, per proper codification the codes were updated: local reaction and lymphadenopathy codes were removed per clinical review.On (b)(6) 2021, it was reported to mentor that the right side was removed on (b)(6) 21 and left side was removed on (b)(6) 21.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 12303637
• Report Number: 1645337-2021-08916
• Device Sequence Number: 3668698
• Product Code: FTR
• UDI-Device Identifier: 00081317000747
• UDI-Public: 00081317000747
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/30/2009
• Device Model Number: 3545507
• Device Catalogue Number: 3545507
• Device Lot Number: 1010996
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 08/12/2021; 09/02/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 08/31/2021; 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR