FDA Adverse Event Injury Summary report: N

INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

MDR report key: 8758170 · Received July 3, 2019

Report

Report Number: 9617229-2019-07907
Event Type: Injury
Date Received: July 3, 2019
Date of Event: May 1, 2019
Report Date: November 19, 2020
Manufacturer: ALLERGAN (COSTA RICA)
Product Code: FTR
UDI-DI: 10888628007321
PMA / PMN Number: P020056
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

DEVICE EVALUATION: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED DEVICE PATCH WITH LOT NUMBER 2903628, CATALOG NUMBER SRF-385, CREASE FOLD, DEFORMATION AND RED PARTICLES ON THE SHELL.

Description of Event or Problem · 0

DEVICE HAS BEEN EXPLANTED.

Additional Manufacturer Narrative · 1

A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF CAPSULAR CONTRACTURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: CAPSULAR CONTRACTURE, BAKER GRADE IV. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

Description of Event or Problem · 1

HEALTHCARE PROFESSIONAL REPORTED A RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE REMAINS IMPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
551006	INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT	PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED	FTR	ALLERGAN (COSTA RICA)	SRF-385	2903628	10888628007321

Patients

Seq	Age	Sex	Outcome	Treatment
1	28 YR		Required Intervention