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

Model Number	TRX-400
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	12/19/2019
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 "capsular contracture" 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: capsular contracture, baker grade iv.
Event or Problem Description
Healthcare professional reported right side capsular contracture, baker grade iv.Device remains implanted.
Additional Manufacturer Narrative
This report is in response to sus voluntary event report mw5092449.
Event or Problem Description
Patient reported via regulatory agency "swelling", "pain", "pain in hands, ribs, back and chest".Patient also reported "problems with hands, arms-extreme problems vascular and neuro in upper extremities", "redness", "palor", "change in temperature" and "several acute bilateral posterior rib fractures"; these events are not device related.Healthcare professional also reported ¿unexplained bilateral mastodynia", "unexplained rib fractures", "concerned for the implant causing possible lymphoma", "unexplained pain" and "capsule appeared to be calcified and thickened.".
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.5., h.6.
Event or Problem Description
Patient reported via regulatory agency "swelling", "pain", "pain in hands, ribs, back and chest".Healthcare professional also reported ¿unexplained bilateral mastodynia", "unexplained rib fractures", "concerned for the implant causing possible lymphoma", "unexplained pain" and "capsule appeared to be calcified and thickened." patient also reported "problems with hands, arms-extreme problems vascular and neuro in upper extremities", "redness", "palor", "change in temperature" and "several acute bilateral posterior rib fractures"; these events are not device related.Device has been explanted and discarded after surgery.

• 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
• MDR Report Key: 9581698
• Report Number: 9617229-2019-23319
• Device Sequence Number: 18966574
• Product Code: FTR
• UDI-Device Identifier: 10888628008502
• UDI-Public: 10888628008502
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/12/2021

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: 02/16/2021
• Device Model Number: TRX-400
• Device Catalogue Number: TRX-400
• Device Lot Number: 2885032
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 09/21/2020; 11/30/2020; 01/13/2021
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 10/21/2020; 12/28/2020; 02/12/2021
• 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
• Patient Age: 53 YR