FDA Adverse Event Injury Summary report: N

STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

MDR report key: 21887083 · Received April 22, 2025

Report

Report Number: 9617229-2025-06651
Event Type: Injury
Date Received: April 22, 2025
Date of Event: March 28, 2025
Report Date: April 22, 2025
Manufacturer: ALLERGAN (COSTA RICA)
Product Code: FTR
PMA / PMN Number: P020056
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

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: RUPTURE.

Additional Manufacturer Narrative · 0

A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS RUPTURE WAS RECEIVED ON MAY 06,2025, WITH LOT NUMBER 2152001. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: ¿ RUPTURE: OBSERVED AN BROKEN ASSESSED AS FOLD FLAW OPENING. AS PER THE INVESTIGATION PROCEDURE, NON PENETRATING NICK WERE OBSERVED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.

Description of Event or Problem · 0

HEALTHCARE PROFESSIONAL REPORTED RUPTURE. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

Description of Event or Problem · 0

HEALTHCARE PROFESSIONAL REPORTED RUPTURE. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
628214	STYLE 15 SILICONE GEL FILLED BREAST IMPLANT	PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED	FTR	ALLERGAN (COSTA RICA)		2152001

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR	Female	Required Intervention