FDA Adverse Event Injury Summary report: N

STYLE 68 SALINE FILLED BREAST IMPLANT

MDR report key: 8621030 · Received May 17, 2019

Report

Report Number: 9617229-2019-03166
Event Type: Injury
Date Received: May 17, 2019
Date of Event: January 15, 2019
Report Date: July 25, 2019
Manufacturer: ALLERGAN (COSTA RICA)
Product Code: FWM
PMA / PMN Number: P990074
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NV
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED FOLD CREASES, WEAR ABRASION AND ONE LINEAR OPENING. A LEAK TEST WAS PERFORMED WHICH IDENTIFIED AN OPENING. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED ONE OPENING CREASE(SHARP). FILL INSPECTION WAS PERFORMED AND IDENTIFIED NO BLOCKAGE IN THE VALVE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS ONE OPENING CREASE(SHARP) ASSESSED AS FOLD (FLAW) OPENING.

Description of Event or Problem · 0

DEVICE WAS EXPLANTED.

Description of Event or Problem · 0

HEALTH PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE WAS EXPLANTED.

Additional Manufacturer Narrative · 1

A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE REASON FOR REOPERATION IS DEFLATION. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

Description of Event or Problem · 1

HEALTH PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
414416	STYLE 68 SALINE FILLED BREAST IMPLANT	PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE	FWM	ALLERGAN (COSTA RICA)		1636304

Patients

Seq	Age	Sex	Outcome	Treatment
1	33 YR		Required Intervention