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

Model Number	TRF-770
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
Date of Event	08/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical product(s): (b)(6) 2019: dyshidrotic lidex ointment (eczema).(b)(6) 2019: breo 100 re: asthma.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 events of seroma and capsular contracture are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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: seroma; capsular contracture, baker grade unknown.
Event or Problem Description
Documentation received from patient representative noting that approximately one month post implant the following events were experienced: serous cloudy drainage; via ultrasound moderate effusion surrounding patient¿s silicone implant was noted; fluid was seen surrounding nearly the entire implant; us breast guidance needle placement yielded 180 ml of cloudy yellow fluid, left breast drain has continued.Drainage, central breast on both sides reveal a dermatitis with fewer vesicles, less weeping, and a drying rash, left breast is consistent with early post infection capsular contraction at this time; left breast tightness; firmness, medial breast induration; left breast firm but softening, and left lump.The following events have been deemed not related to the device: acute bronchitis/wheezing (cough, fever, chest congestion, fatigue), insomnia, decreased exercise tolerance, asthma, weight gain, fatigue, and anxiety.Affected side is left.The device remains implanted.

• 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: 9949965
• Report Number: 9617229-2020-07239
• Device Sequence Number: 16926956
• Product Code: FTR
• UDI-Device Identifier: 10888628008427
• UDI-Public: 10888628008427
• Combination Product (Y/N): N
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2020

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: 03/29/2021
• Device Model Number: TRF-770
• Device Catalogue Number: TRF-770
• Device Lot Number: 2905780
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 04/10/2020
• 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: 31 YR
• Patient Weight: 95