MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 68 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number 68-360

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

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 and port leak and/or damage.

Event Description

Healthcare professional reported right side deflation.Healthcare professional later reported ¿leak at port site." device has been explanted and replaced.

Event Description

Healthcare professional reported right side deflation.Healthcare professional later reported ¿leak at port site." device has been explanted and replaced.

Manufacturer Narrative

Device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ deflation and port leak and/or damage: observed one opening on valve bond edge side assessed as unidentified (tear) opening and delamination on the plug strap side assessed as adhesive failure.Additional observation: ¿ white particles observed inside the device.No further actions are required as no issues with the manufacturing process are observed.Additional, changed, and/or corrected data: d9, h3, h6.

• Brand Name: STYLE 68 SALINE FILLED BREAST IMPLANT
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 17906948
• MDR Text Key: 325308587
• Report Number: 9617229-2023-16252
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2017
• Device Catalogue Number: 68-360
• Device Lot Number: 2481886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 64 KG