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-275
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In response to fda report number: mw5101414.No contact information was provided for the initial reporter, therefore additional event, product, and/or patient details are not attainable.Reason for reoperation: capsular contracture baker grade unknown.
Event or Problem Description
Patient reported via regulatory agency a left side "skin rashes." patient additionally reported "abnormal lab test after receiving allergan textured breast implants, positive ana, abnormal thyroid even on treatment, arthritis, significant increase in all over joint stiffness and pain, thyroid nodules, difficulty swallowing, difficulty breathing at times, insomnia, fatigue dry eyes, and stomach pain"; these events are not device related.Patient reported capsular contracture baker grade unknown.The device has been explanted.
Event or Problem Description
Patient reported via regulatory agency a left side "skin rashes." patient additionally reported "abnormal lab test after receiving allergan textured breast implants, positive ana, abnormal thyroid even on treatment, arthritis, significant increase in all over joint stiffness and pain, thyroid nodules, difficulty swallowing, difficulty breathing at times, insomnia, fatigue dry eyes, and stomach pain"; these events are not device related.Patient reported capsular contracture baker grade unknown.The device has been explanted.
Additional Manufacturer Narrative
Device evaluation: device photograph(s) for the device related to the reported event of arthritis-rheumatoid, lupus, capsular contracture and skin rash/dermatitis was reviewed on 30-ago-22.Visual analysis of the photographs identified red biological tissue in the shell.Device analysis performed through photographs, due to the impossibility to perform microscopic analysis it is not possible to determine the most likely failure mode.Refer to ps-qp-onev-115717:covid-19 quality plan - complaint handling.

• 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 13318502
• Report Number: 9617229-2022-00437
• Device Sequence Number: 17364729
• Product Code: FTR
• UDI-Device Identifier: 10888628030855
• UDI-Public: 10888628030855
• 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: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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: 09/07/2021
• Device Model Number: TCM-275
• Device Catalogue Number: TCM-275
• Device Lot Number: 2970519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2016
• 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: 57 YR
• Patient Sex: Female