MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number N-TSX310

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seroma (2069)

Event Type  Injury  

Event Description

Patient reported right side 'breast turned'.Healthcare professional later reported 'lobulated contours, few radial folds, minimal amount of peri-implant seroma, 2mm capsular'.The device has been explanted.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Photographic device evaluation: a review of the device through photographs noted the event could not be observed as it is a physiological complication.The event of seroma 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: seroma.

Manufacturer Narrative

Additional, changed, and/or corrected data.

Event Description

Patient reported right side 'breast turned'.Healthcare professional later reported 'lobulated contours, few radial folds, minimal amount of peri-implant seroma, 2mm capsular'.The device has been explanted.

• Brand Name: INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
• Type of Device: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 18951321
• MDR Text Key: 338259970
• Report Number: 9617229-2024-04853
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P020056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2018
• Device Catalogue Number: N-TSX310
• Device Lot Number: 2458749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/16/2024
• Date Device Manufactured: 05/16/2013
• 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 Sex: Female
• Patient Weight: 58 KG