MAUDE Adverse Event Report: MENTOR TEXAS UNKNOWN SALINE IMPLANTS TEXTURED; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	3542915
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Autoimmune Reaction (1733); Capsular Contracture (1761)
Date of Event	01/01/2000
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.Since no lot number was provided, no manufacturing record evaluation review could be performed.Reason for device explant and/or reoperation: n/a note: facility information: (b)(6).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a breast augmentation primary with an unknown saline implants textured (teardrop) and suffered from bilateral capsular contracture, bilateral rupture, autoimmune reaction.The patient suffered from hardening of breasts, health complications, hysterectomy due to uterine tumor, three brain tumors, crohn's disease, brain fog, lethargic with no energy, chest pain.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch is for the right breast implant.

• Brand Name: UNKNOWN SALINE IMPLANTS TEXTURED
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9615674
• Report Number: 1645337-2020-01080
• Device Sequence Number: 546895
• Product Code: FWM
• UDI-Device Identifier: 00081317001898
• UDI-Public: 00081317001898
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2020

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 Model Number: 3542915
• Device Catalogue Number: UNK_SALINE IMPLANTS TEXTURED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 01/22/2020
• 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: 18 YR