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

Catalog Number	3548007
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/22/2018
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 device history record review is in progress.Once completed, a supplemental report will be submitted.Concomitant products: mentor memorygel breast implant 800cc gel breast prosthesis, cat.#3548007, lot number unknown.(b)(4).
Event or Problem Description
It was reported that a (b)(6) -year-old caucasian female patient underwent a breast augmentation revision procedure with mentor memorygel breast implant 800cc gel breast prostheses that both ruptured after implantation.As a result, the patient will undergo bilateral explantation on (b)(6) 2018.This medwatch report is for the 1st of two breast prostheses.
Additional Manufacturer Narrative
On 06/06/2018, the device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.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: 7550120
• Report Number: 1645337-2018-03275
• Device Sequence Number: 1775960
• Product Code: FTR
• UDI-Device Identifier: 00081317000778
• UDI-Public: 00081317000778
• Combination Product (Y/N): N
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2018

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: 08/31/2001
• Device Catalogue Number: 3548007
• Device Lot Number: 149878
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 06/27/2018
• 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: 56 YR