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

Model Number	3341509
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994)
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: the patient has not undergone explantation or reoperation at this time.Concomitant products: 400cc mentor memorygel breast implant, catalog # 3504001bc, serial # (b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that an (b)(6) year-old female patient underwent a breast reconstruction revision with a 680cc gel mentor memoryshape breast implant and experienced postoperative right-sided breast pain and breast cyst.Patient reported that she has had cancer before and noticed a bump on her right side.Patient had ultrasound and mammogram performed and a cyst was found, doctor confirmed it was small and free of cancer.Patient also reported pain on the right side and that the breast appears severely dimpled.As a result, the patient is planning on explantation, but at the time of this report, mentor has received no information regarding an expected explantation date.
Additional Manufacturer Narrative
On 22-jan-2020, a manufacturing record evaluation (mre) was completed, 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.Manufactured date was updated to 15-mar-2017 per mre.Manufacturer¿s reference number: (b)(4).

• 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
• MDR Report Key: 9499763
• Report Number: 1645337-2019-25977
• Device Sequence Number: 2002066
• Product Code: FTR
• UDI-Device Identifier: 00081317005131
• UDI-Public: 00081317005131
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

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: 03/17/2022
• Device Model Number: 3341509
• Device Catalogue Number: 3341509
• Device Lot Number: 7445207
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 01/23/2020
• 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: Other
• Patient Age: 87 YR