FDA Adverse Event Injury Summary report: N

STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

MDR report key: 11120836 · Received January 5, 2021

Report

Report Number: 9617229-2020-22541
Event Type: Injury
Date Received: January 5, 2021
Date of Event: February 15, 2020
Report Date: January 5, 2021
Manufacturer: ALLERGAN (COSTA RICA)
Product Code: FTR
PMA / PMN Number: P040046
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ARTICLE CITATION: PREPECTORAL BREAST RECONSTRUCTION WITH TILOOP® BRA POCKET: A SINGLE CENTER PROSPECTIVE STUDY. F. LO TORTO, M. MARCASCIANO, J. KACIULYTE, U. REDI, L. BARELLINI, A. DE LUCA, A. PERRA, J. M. FRATTAROLI, E. CAVALIERI, G. DI TARANTO, M. GRECO AND D. CASELLA. EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES. FEB 2020; 24 (3): 991-999. THE EVENT OF WOUND DEHISCENCE 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: NOT APPLICABLE. THE DEVICE REMAINS IMPLANTED, AND THE REPORTED EVENT HAS RESOLVED.

Description of Event or Problem · 1

ARTICLE "PREPECTORAL BREAST RECONSTRUCTION WITH TILOOP® BRA POCKET: A SINGLE CENTER PROSPECTIVE STUDY" DISCUSSES ONE PATIENT WHO EXPERIENCED "DELAY IN SCARRING AND RESULTED IN PARTIAL THICKNESS WOUND DEHISCENCE" AFTER SUBGLANDULAR PLACEMENT OF NATRELLE 410 DEVICE. TREATED WITH AMBULATORY WOUND DRESSINGS AND RESOLVED IN 16 DAYS. SIDE UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
13133	STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT	PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED	FTR	ALLERGAN (COSTA RICA)		NI

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention