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

Model Number	TRL-230
Medical Device Problem Codes	Material Rupture (1546); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
Date of Event	08/06/2019
Type of Reportable Event	Serious Injury
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.The event of capsular contracture 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 iii.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported right side capsular contracture, baker grade iii.Device remains implanted.
Event or Problem Description
Healthcare professional additionally reported right side "bloody seroma" and a "double bubble deformity".Healthcare professional also reported ¿nipple has serous drainage due to bilateral piercings¿; this event is not device related.
Additional Manufacturer Narrative
The event of seroma-late is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: underweight, opening, brown particles.A microscopic analysis was performed which identify sharp edge opening assessed an unidentified tear opening.A dimension measurement in the shell was performed which identify the thickness within specification.Based on the device analysis the final assessment is: a sharp opening due to an unidentified (tear) opening.
Event or Problem Description
Patient representative reported "persistent and increasing pain" and "implant in question had ruptured." device has been explanted.

• 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: 9318916
• Report Number: 9617229-2019-17687
• Device Sequence Number: 13934981
• Product Code: FTR
• UDI-Device Identifier: 10888628007697
• UDI-Public: 10888628007697
• Combination Product (Y/N): N
• Initial Reporter State: MA
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2020

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: 05/26/2020
• Device Model Number: TRL-230
• Device Catalogue Number: TRL-230
• Device Lot Number: 2763449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 12/10/2019; 03/16/2020
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 01/08/2020; 04/15/2020
• 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: 23 YR