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

Model Number	TSF-295
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Fistula (1862); Granuloma (1876); Inflammation (1932); Necrosis (1971); Seroma (2069)
Date of Event	04/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported ¿swelling and liquid around the implant¿.Patient representative reported that the patient is "very concerned." healthcare professional reported ¿pain, edema and yellowish discharge from left breast, ¿discontinuity of skin in the breast¿, ¿relapsing seroma¿, possible rupture, chronic and acute inflammatory process with granulomatous element associated to fibrosis in the sample¿, and the patient performed a decompression puncture, drained the breast out of necessity (due to the large volume in the breast), in addition to the seroma being ¿trying to get out of the scar¿.The device remains implanted.
Additional Manufacturer Narrative
The events of granuloma, seroma-late and necrosis are a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Reason for reoperation: rupture, granuloma, seroma-late, and necrosis.Further information from the reporter regarding the events, product, and patient details have been requested.No additional information is available at this time.This report is submitted beyond 30 calendar days from allergan¿s receipt due to a system error preventing allergan from submitting reports via emdr.The system error has been resolved at this time and an investigation has been initiated into this occurrence.
Event or Problem Description
Patient reported ¿swelling and liquid around the implant¿.Patient representative reported that the patient is "very concerned." healthcare professional reported ¿pain, edema and yellowish discharge from left breast, ¿discontinuity of skin in the breast¿, ¿relapsing seroma¿, possible rupture, chronic and acute inflammatory process with granulomatous element associated to fibrosis in the sample¿, and the patient performed a decompression puncture, drained the breast out of necessity (due to the large volume in the breast), in addition to the seroma being ¿trying to get out of the scar¿.The device remains implanted.
Event or Problem Description
The health professional additionally reported that the patient experienced "cutaneous fistula" and "inflammatory process." reported device has been explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.

• Brand Name: INSPIRA TEXTURED 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; CS
• MDR Report Key: 10049576
• Report Number: 9617229-2020-06666
• Device Sequence Number: 19518712
• Product Code: FTR
• UDI-Device Identifier: 10888628034105
• UDI-Public: 10888628034105
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2020

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: 05/31/2022
• Device Model Number: TSF-295
• Device Catalogue Number: N-TSX400
• Device Lot Number: 3061273
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 05/12/2020; 05/14/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 05/15/2020; 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR