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

Catalog Number SRF-345

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Foreign Body Reaction (1868)

Event Type  Injury  

Event Description

Healthcare professional reported right side exposure of device.Device has been explanted.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.The event of exposure 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: exposure.

Manufacturer Narrative

Device evaluation: based on the device analysis grid, the assessments of the complaint are: exposure: unable to confirm as it is a medical event not related to the device.Additional observations: crease flat observed.Observed opening striated on anterior side assessed as surgical damage.No further actions are required as no manufacturing issues are observed.

Event Description

Healthcare professional reported right side exposure of device.Device has been explanted.

• Brand Name: INSPIRA SMOOTH 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
• 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: 17815367
• MDR Text Key: 324210242
• Report Number: 9617229-2023-15553
• Device Sequence Number: 1
• Product Code: FTR
• UDI-Device Identifier: 10888628007307
• UDI-Public: 10888628007307
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020056
• 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: 11/22/2023

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 Catalogue Number: SRF-345
• Device Lot Number: 3554179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• 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: 73 KG