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

Model Number	TRF-295
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: rupture.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported ¿left side -tenderness, swelling, pain on breast.¿ and a ruptured device diagnosed by mri.The device has been explanted.
Additional Manufacturer Narrative
Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-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: analysis of the returned device identified weight to the spec, yellow particles, crease fold and deformation.Cloudy in the gel observed after autoclave cycle.Base on the device analysis the final assessment is: the unit is not rupture.No issues found related with the manufacturing process additional, changed, and/or corrected data: d.4, d.10, h.3, h.4, h.6.
Event or Problem Description
Healthcare professional reported ¿left side -tenderness, swelling, pain on breast.¿ and a ruptured device diagnosed by mri.The 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 (AUSTIN); 301 w howard lane; suite 100; austin TX 78753
• MDR Report Key: 8897742
• Report Number: 9617229-2019-12402
• Device Sequence Number: 298140
• Product Code: FTR
• UDI-Device Identifier: 10888628008274
• UDI-Public: 10888628008274
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

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: 05/11/2018
• Device Model Number: TRF-295
• Device Catalogue Number: N-TRF295
• Device Lot Number: 2459257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 02/03/2020
• 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: 38 YR