FDA Adverse Event Injury Summary report: N

MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

MDR report key: 7820447 · Received August 27, 2018

Report

Report Number: 1645337-2018-05213
Event Type: Injury
Date Received: August 27, 2018
Date of Event: July 24, 2018
Report Date: August 7, 2018
Manufacturer: MENTOR TEXAS
Product Code: FWM
UDI-DI: 00081317001409
PMA / PMN Number: P990075
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NV, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED ON 8/14/2018, 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. CONCOMITANT PRODUCTS: RIGHT MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 325CC SALINE PROSTHESIS, CATALOG: 3502325, SERIAL NUMBER: (B)(4), LOT: 6950240. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 325CC SALINE PROSTHESES. CAPSULAR CONTRACTURE BAKER GRADE IV ON THE LEFT BREAST PROSTHESIS WAS CONFIRMED POST PROCEDURE AT THE DOCTOR¿S OFFICE. AS A RESULT, THE BREAST PROSTHESIS WAS EXPLANTED FROM THE PATIENT ON (B)(6) 2018.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
658632	MENTOR SMOOTH ROUND MODERATE PLUS PROFILE	PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE	FWM	MENTOR TEXAS		6920287	00081317001409

Patients

Seq	Age	Sex	Outcome	Treatment
1	33 YR		Required Intervention