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

Catalog Number	3543607MC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930); Necrosis (1971); No Code Available (3191)
Date of Event	06/01/2018
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 (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: abscess, necrosis.Concomitant products: 360cc mentor memorygel breast implant catalog: 3543607mc, lot: 7381668, sn: (b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old caucasian female patient who underwent vertical mastopexy and primary breast augmentation with two 360cc mentor memorygel breast implants on (b)(6) 2018, had recurrent problems with cellulitis of the left breast which apparently responded to cipro and keflex on two occasions.The patient had recurrent erythema and swelling of the left breast that occurred approximately (b)(6) 2019.The patient was again treated with cipro and keflex.A needle was stuck into the area of maximum induration and the results of this are unknown.Since that time, the patient had fevers, swelling, pain and erythema, of the left breast.The patient was seen in the er where she was noted to be stable but presented with a hot, tender, painful and swollen left breast.The patient had a wbc of 11,000.Per reporter, the infection was also spreading to the patient's left eye.There was an area that was bulging along the vertical limb on the left side which is where the surgeon felt was likely an abscess that was about to rupture.The patient underwent removal of the left intact breast implant and incision and drainage of the 100-150 ml of a non foul smelling yellow/brown fluid left breast abscess on (b)(6) 2019.This abscess/seroma fluid was tested and returned negative for malignancy.The fluid also returned negative for aerobic and anaerobic bacteria.
Additional Manufacturer Narrative
On (b)(6) 2019, mentor became aware that patient code, infection, for the left breast fat necrosis the patient had also experienced, was erroneously excluded from the initial report sent on (b)(6) 2019.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: 8680799
• Report Number: 1645337-2019-13478
• Device Sequence Number: 2016503
• Product Code: FTR
• UDI-Device Identifier: 00081317004424
• UDI-Public: 00081317004424
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2019

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: 07/14/2021
• Device Catalogue Number: 3543607MC
• Device Lot Number: 7353563
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 06/13/2019
• 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: 61 YR