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

Model Number	3541408
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); No Code Available (3191)
Date of Event	10/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.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: currently unknown.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient underwent a breast surgery on (b)(6) 2013 with a 440cc mentor memoryshape breast implant.On (b)(6) 2019, the patient's impacted device was explanted.At the time of this report, mentor has received no indication of the patient's medical diagnosis from a physician, nor has mentor been provided with any access to cytology / pathology reports and lab results.If additional information becomes available, mentor will submit those updates in a supplemental report.
Additional Manufacturer Narrative
Mentor received an update on the events submitted in the initial report.The patient had developed a late onset seroma on the left side.After their explantation procedure, the patient's alcl testing returned negative.A follow-up is still in progress for additional information.If additional information becomes available, then mentor will submit those updates in another supplemental report.The patient code for "seroma" has been added to this supplemental report in light of this new information.Additionally, mentor became aware of event details that were submitted in error in the initial report sent on (b)(6) 2019.It was reported that the mentor failure analysis lab received the device for evaluation; however, concomitant medical products was mistakenly left blank and without a checkmark.The proper return receipt date and checkmark have been updated on this supplemental report.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The product investigation was completed.Device investigation summary: during visual evaluation no apparent damage was observed.The manufacturing records were reviewed, and the manufacturing criteria were met prior to the release of this lot.Excessive postoperative accumulation and/or transient re-accumulation of fluid around an implant most likely occur soon after surgery; however, it can occur at any time.Symptoms from seroma may include swelling, pain, and bruising.While the body absorbs small hematomas and seromas, some will require surgery.Seromas presenting after the immediate post-operative period may require additional work-up by the surgeon.Seroma is a known complication associated with this surgery and is referenced in our current product insert data sheet.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: 9385485
• Report Number: 1645337-2019-23875
• Device Sequence Number: 480587
• Product Code: FTR
• UDI-Device Identifier: 00081317005490
• UDI-Public: 00081317005490
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2019

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: 07/31/2018
• Device Model Number: 3541408
• Device Catalogue Number: 3541408
• Device Lot Number: 6740466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 12/03/2019; 01/13/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 12/20/2019; 01/28/2020
• 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: Required Intervention
• Patient Age: 58 YR