MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE MM 640CC; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3541608
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Breast Mass (2439); Wrinkling (2613); No Code Available (3191)
Date of Event	08/01/2020
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: na.(b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old caucasian female who underwent primary breast reconstruction with a mentor memoryshape¿ 640cc silicone prosthesis experienced bilateral rupture and bilateral breast lumps post procedure.The patient reported headaches, a bit of vertigo/tunnel vision, hair loss, dry skin and hair.The issues has not been confirmed by the physician.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This report belongs to right prosthesis.
Additional Manufacturer Narrative
¿after clinical / secondary review of this file performed on november 5, 2020, it was decided to remove patient code breast mass, and patient experience code deflation / add patient code wrinkling to more accurately capture the reported event.¿ manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE MM 640CC
• 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: 10705873
• Report Number: 1645337-2020-13289
• Device Sequence Number: 14514545
• Product Code: FTR
• UDI-Device Identifier: 00081317005520
• UDI-Public: 00081317005520
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020

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: 04/23/2022
• Device Model Number: 3541608
• Device Catalogue Number: 3541608
• Device Lot Number: 7455055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 11/16/2020
• 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: 67 YR