FDA Adverse Event Injury Summary report: N

INSPIRA SMOOTH COHESIVE SILICONE GEL FILLED BREAST IMPLANT

MDR report key: 17886057 · Received October 6, 2023

Report

Report Number: 9617229-2023-16144
Event Type: Injury
Date Received: October 6, 2023
Date of Event: September 13, 2023
Report Date: November 27, 2023
Manufacturer: ALLERGAN (COSTA RICA)
Product Code: FTR
UDI-DI: 10888628029934
PMA / PMN Number: P020056
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

DEVICE EVALUATION: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: ¿ RUPTURE: OBSERVED THREE OPENINGS ON ANTERIOR ASSESSED AS SURGICAL DAMAGE. ADDITIONAL OBSERVATIONS: ¿ CREASE FLAT OBSERVED ON THE DEVICE.

Additional Manufacturer Narrative · 0

A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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.

Description of Event or Problem · 0

HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL REPORTED "HOLE, NON-SPECIFIC" VIA RGA. DEVICE HAS BEEN EXPLANTED AND REPLACED.

Description of Event or Problem · 0

HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE RUPTURE. HEALTHCARE PROFESSIONAL REPORTED "HOLE, NON-SPECIFIC" VIA RGA. DEVICE HAS BEEN EXPLANTED AND REPLACED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1270125	INSPIRA SMOOTH COHESIVE SILICONE GEL FILLED BREAST IMPLANT	PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED	FTR	ALLERGAN (COSTA RICA)		3551041	10888628029934

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR	Female	Required Intervention