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

Model Number	TCM-310
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Capsular Contracture (1761); Inflammation (1932); Irritation (1941)
Date of Event	08/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: visual analysis of the returned device identified; crease flat, deformation and the weight the device within specification.After autoclave cycle, voids and cloudy gel was observed.Based on the device analysis the final assessment is: - no issues found related with the manufacturing process.The events of pain, edema, inflammation/irritation, capsular contracture, and anxiety product/procedure are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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: "red, inflamed blister on inner pole of left breast and pain," and "patient concern with the product.".
Event or Problem Description
Healthcare professional reported "there was fluid and capsule was irritated and inflamed on the left breast.On the patient's left breast, there was a blister on the inner pole and it was inflamed and red." healthcare professional additionally reported implant exchange from texture to smooth and capsular contracture, baker grade unknown.This record is for the left side.Device was explanted.

• Brand Name: INSPIRA TEXTURE COHESIVE 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: 9905556
• Report Number: 9617229-2020-04585
• Device Sequence Number: 2815023
• Product Code: FTR
• UDI-Device Identifier: 10888628030879
• UDI-Public: 10888628030879
• Combination Product (Y/N): N
• Initial Reporter State: NV
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2020

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: 09/06/2021
• Device Model Number: TCM-310
• Device Catalogue Number: TCM-310
• Device Lot Number: 2970521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 03/31/2020
• 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: 35 YR