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

Model Number	TSF-180
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	10/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event of capsular contracture baker grade unknown 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: capsular contracture baker grade unknown and inflation.
Event or Problem Description
Healthcare professional reported left side capsular contracture baker grade unknown, cyst, pain, crease/folding, "big posterior collection in left implant with thin internal septations¿, and ¿breast volume increase in left side for 3 months¿ on left side, device remains implanted.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to (b)(4) has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.
Event or Problem Description
Additionally, healthcare professional reported the baker grade as iv.

• 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: 9580290
• Report Number: 9617229-2019-23137
• Device Sequence Number: 18969373
• Product Code: FTR
• UDI-Device Identifier: 10888628034051
• UDI-Public: 10888628034051
• 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: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2020

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: 10/26/2022
• Device Model Number: TSF-180
• Device Catalogue Number: N-TSF180
• Device Lot Number: 3118951
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 01/17/2020; 10/09/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 03/03/2020; 11/06/2020
• 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: 37 YR