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

Model Number	SCX-400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
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: 3rd degree burns in the area that contained the implants.And "it felt like the gel heated up in my chest." 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.
Event or Problem Description
Patient reported 3rd degree burns in the area that contained the implants and "it felt like the gel heated up in my chest." this record is for an unknown side.Device status is unknown.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5,d6a,d6b,h6.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The event of burn is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Device evaluation: visual analysis of the returned device identified one extended opening and fold creases.A weight test of the device was verified and the device was within specification.A microscopic analysis was performed which identified one opening striated and wear abrasion.Based on the device analysis the final assessment is: - one opening striated in the side anterior assessed as surgical damage.
Event or Problem Description
Patient reported right side "3rd degree burns in the area that contained the implants", "burn through the clothing", and "it felt like the gel heated up in my chest".Healthcare professional reported a "bad t shirt sunburn" implant exchange.The device has been explanted and replaced.

• Brand Name: INSPIRA SMOOTH 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
• MDR Report Key: 11756600
• Report Number: 9617229-2021-06389
• Device Sequence Number: 4138782
• Product Code: FTR
• UDI-Device Identifier: 10888628030299
• UDI-Public: 10888628030299
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2021

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: 01/05/2025
• Device Model Number: SCX-400
• Device Catalogue Number: SCX-400
• Device Lot Number: 3412069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 06/08/2021; 09/30/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 07/07/2021; 10/22/2021
• 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