FDA Adverse Event Injury Summary report: N

STYLE 68 SALINE FILLED BREAST IMPLANT

MDR report key: 22081626 · Received May 23, 2025

Report

Report Number: 9617229-2025-08614
Event Type: Injury
Date Received: May 23, 2025
Date of Event: November 2, 2016
Report Date: May 23, 2025
Manufacturer: ALLERGAN (COSTA RICA)
Product Code: FWM
UDI-DI: 10888628000308
PMA / PMN Number: P990074
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THIS IS A FOLLOW-UP REPORT TO A MEDWATCH SUBMITTED UNDER MANUFACTURE REPORT NUMBER 9617229-2025-0000036. 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: DEFLATION. DEVICE EVALUATION: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: USE ERROR: OBSERVED, ONE OPENING ASSESSED AS SURGICAL DAMAGE. DEFLATION: OBSERVED, ONE OPENING ASSESSED AS FOLD FLAW OPENING. AS PER THE INVESTIGATION PROCEDURE CREASE, NON-PENETRATING NICK AND WEAR ABRASION WERE OBSERVED. 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 LEFT SIDE DEFLATION. IT WAS ADDITIONALLY REPORTED "HOLE ON BOTTOM". THE DEVICE HAS BEEN EXPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
326425	STYLE 68 SALINE FILLED BREAST IMPLANT	PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE	FWM	ALLERGAN (COSTA RICA)		2881900	10888628000308

Patients

Seq	Age	Sex	Outcome	Treatment
1	38 YR	Female	Required Intervention