FDA Adverse Event Injury Summary report: N

UNKNOWN

MDR report key: 8714531 · Received June 19, 2019

Report

Report Number: 1645337-2019-14012
Event Type: Injury
Date Received: June 19, 2019
Date of Event: October 30, 2017
Report Date: May 29, 2019
Manufacturer: MENTOR TEXAS
Product Code: FTR
PMA / PMN Number: UNK
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. [(B)(4)].

Description of Event or Problem · 1

THIS COMPLAINT IS FROM A LITERATURE SOURCE. AS REPORTED IN THE LITERATURE PUBLICATION ENTITLED, ¿BREAST RECONSTRUCTION IN POLAND SYNDROME PATIENTS WITH LATISSIMUS DORSI MYO FLAP AND IMPLANT: AN EFFICIENT ENDOSCOPIC APPROACH USING SINGLE TRANSVERSE AXILLARY INCISION.¿ 1 PATIENT WITH POLAND SYNDROME WHO UNDERWENT ELDM (A LATISSIMUS DORSI MYO FLAP) + IMPLANT BREAST RECONSTRUCTION DEVELOPED MINOR AXILLARY WOUND DEHISCENCE. THIS STUDY AIMS TO INTRODUCE AN EFFICIENT ENDOSCOPIC TECHNIQUE TO PERFORM BREAST RECONSTRUCTION IN POLAND SYNDROME PATIENTS WITH A LATISSIMUS DORSI MYO FLAP AND AN IMPLANT USING A SINGLE TRANSVERSE AXILLARY INCISION (ELDM + IMPLANT) AND TO EVALUATE ITS SAFETY AND EFFECTIVENESS. METHODS: A PROSPECTIVE STUDY WAS DESIGNED TO RECRUIT POLAND SYNDROME CANDIDATES FOR LATISSIMUS DORSI MYO FLAP (LDM) PLUS IMPLANT BREAST RECONSTRUCTION IN THE DEPARTMENT OF AESTHETIC AND RECONSTRUCTIVE BREAST SURGERY, PLASTIC SURGERY HOSPITAL, (B)(6) COLLEGE, (B)(6), FROM JANUARY 2012 TO OCTOBER 2017.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
508160	UNKNOWN	UNK	FTR	MENTOR TEXAS

Patients

Seq	Age	Sex	Outcome	Treatment
1	21 YR		Other