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

Catalog Number	TRLP-205
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Seroma (2069)
Date of Event	06/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The event of seroma-late is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Reason for reoperation: fluid collection.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Patient reported a left-side "fluid collection in the nipple area adjacent to the implant." device remains implanted.
Additional Manufacturer Narrative
In response to fda report number: mw5088691 the event of inflammation/irritation 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: deformation, fold yellow particles.And was observed after autoclave cycle: bubbles in gel, cloudy gel.A weight test of the explanted material was verified and it was within specification.Based on the device analysis the final assessment is: no observations found related with the complaint reported by the physician.
Event or Problem Description
A patient reported via a regulatory agency that their ¿breast were inflamed and became healed and red¿ and ¿got really sick for a week.Coughing, fever and breast kept getting bigger".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 (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 8932731
• Report Number: 9617229-2019-11042
• Device Sequence Number: 16206588
• Product Code: FTR
• UDI-Device Identifier: 10888628007840
• UDI-Public: 10888628007840
• Combination Product (Y/N): N
• 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: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2019

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: 07/09/2021
• Device Catalogue Number: TRLP-205
• Device Lot Number: 2946952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 10/11/2019
• 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: 32 YR