FDA Adverse Event Injury Summary report: N

MENTOR SMOOTH ROUND MODERATE PROFILE

MDR report key: 7497328 · Received May 8, 2018

Report

Report Number: 1645337-2018-02742
Event Type: Injury
Date Received: May 8, 2018
Date of Event: April 11, 2018
Report Date: April 12, 2018
Manufacturer: MENTOR TEXAS
Product Code: FWM
UDI-DI: 00081317001317
PMA / PMN Number: P990075
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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 DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: MENTOR SMOOTH ROUND MODERATE PROFILE 575CC SALINE, CATALOG #3501690, LOT #5821010, SN #(B)(4). (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT A (B)(6)-YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND MODERATE PROFILE 575CC SALINE BREAST PROSTHESES. DEFLATION ON THE LEFT BREAST PROSTHESIS WAS DETERMINED. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
339661	MENTOR SMOOTH ROUND MODERATE PROFILE	PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE	FWM	MENTOR TEXAS		5821010	00081317001317

Patients

Seq	Age	Sex	Outcome	Treatment
1	45 YR		Other