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

Model Number	SSLP-300
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Drug Resistant Bacterial Infection (4553)
Date of Event	06/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported left side "leak, possible rupture¿, ¿emotional problems and depression persisted with occasional suicidal thoughts¿, and ¿diagnosed with a mrsa (methicillin-resistant staphylococcus aureus) infection in armpits as a result of chemical toxins leaking from her lymph nodes¿.Additional events of ¿chemical odor from her armpits¿, ¿skin problems, cystic acne, hormone imbalance problems, insomnia, chronic fatigue, cognitive problems and difficulty concentrating during basic conversations¿, ¿fatigue¿, ¿increased alcohol intolerance¿, ¿hypoxia¿, ¿adrenal fatigue¿, ¿now struggles with ptsd¿, which are not device related.Device has been explanted.
Additional Manufacturer Narrative
Health effect impact code : f2201 biopsy.A review of the device history record has been completed.No deviations or non-conformances noted.The event of infection (late onset) 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: rupture, ¿diagnosed with a mrsa (methicillin-resistant staphylococcus aureus) infection in armpits.".

• Brand Name: INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: 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: 16627459
• Report Number: 9617229-2023-04541
• Device Sequence Number: 5334211
• Product Code: FTR
• UDI-Device Identifier: 10888628032736
• UDI-Public: 10888628032736
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/03/2021
• Device Model Number: SSLP-300
• Device Catalogue Number: SSLP-300
• Device Lot Number: 3004020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 64 KG