MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 68 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	68LP-175
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Unspecified Infection (1930)
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.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time the event of infection 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.Device labeling: potential adverse events that may occur with saline-filled breast implant surgery include: reoperation,pain, wrinkling, asymmetry, implant palpability/visibility, implant removal, capsular contracture,changes in nipple and breast sensation, implant displacement/migration, implant deflation, scarring,infection, hematoma/seroma, breastfeeding complications, implant extrusion, necrosis, delayed wound healing, breast tissue atrophy/chest wall deformity, calcium deposits, and lymphadenopathy.Infection ¿ in rare instances, acute infection may occur in a breast with implants.The signs of acute infection include erythema, tenderness, fluid accumulation, pain, and fever.Very rarely, toxic shock syndrome, a potentially life-threatening condition, has been reported in women after breast implant surgery.It is characterized by symptoms that occur suddenly and include page 10: high fever (102°f, 38.8°c or higher), vomiting, diarrhea, a sunburn-like rash, red eyes, dizziness, lightheadedness, muscle aches, and drops in blood pressure, which may cause fainting.Patients should be advised to contact a physician immediately for diagnosis and treatment for any of these symptoms.
Event or Problem Description
Patient reported left side infection and excessive swelling and discharge.The patient also reported "fluid built up around the implant," not feeling well, and described having "freezing and chills," "a horrible fever." the device has been explanted.

• Brand Name: STYLE 68 SALINE FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 7428303
• Report Number: 9617229-2018-02665
• Device Sequence Number: 16448262
• Product Code: FWM
• UDI-Device Identifier: 10888628000537
• UDI-Public: 10888628000537
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2018

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: 03/19/2021
• Device Catalogue Number: 68LP-175
• Device Lot Number: 3042328
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 04/13/2018
• 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