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

Model Number	TRM-360
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	08/15/2017
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 wound dehiscence 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: wound dehiscence.
Event or Problem Description
Patient reported right side exchange of textured breast implants due to the patient¿s concern with the product, "pseudomonas infection from open wound under the right breast", bilateral revision surgery with left side implant released due to devices "sitting high like "man pectorals", lumpy, bulging, and deformed, as well as 4 surgeries with devices.Patient also reported "it feels as if the implant is pushing its' way through towards the sternum." device remains implanted.
Additional Manufacturer Narrative
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.Additional, changed, and/or corrected data:.
Event or Problem Description
Device has been explanted.
Event or Problem Description
Patient reported right side exchange of textured breast implants due to the patient¿s concern with the product, "pseudomonas infection from open wound under the right breast", bilateral revision surgery with left side implant released due to devices "sitting high like "man pectorals", lumpy, bulging, and deformed, as well as 4 surgeries with devices.Patient also reported "it feels as if the implant is pushing its' way through towards the sternum." device has been explanted.
Additional Manufacturer Narrative
Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-0101-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.
Event or Problem Description
Patient reported right side exchange of textured breast implants due to the patient¿s concern with the product, "pseudomonas infection from open wound under the right breast", bilateral revision surgery with left side implant released due to devices "sitting high like "man pectorals", lumpy, bulging, and deformed, as well as 4 surgeries with devices.Patient also reported "it feels as if the implant is pushing its' way through towards the sternum." device has been explanted.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified the overweight, yellow biological tissue and red particles in the shell.Bubbles in the gel observed after autoclave cycle.The device is weighed again in the mo502-65-004 and it is within specification.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.

• 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 9772081
• Report Number: 9617229-2020-02748
• Device Sequence Number: 16747031
• Product Code: FTR
• UDI-Device Identifier: 10888628008113
• UDI-Public: 10888628008113
• Combination Product (Y/N): N
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/09/2020

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: 06/27/2020
• Device Model Number: TRM-360
• Device Catalogue Number: TRM-360
• Device Lot Number: 2781230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 03/05/2020; 03/06/2020; 04/30/2022
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 04/20/2020; 10/09/2020; 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2015
• 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: 35 YR
• Patient Sex: Female