MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 168 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	168-700
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Lymphoma (3263)
Date of Event	11/15/2019
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 lymphoma-alcl-suspected 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: "diagnosed with bia-alcl" and the recall.Date of alcl diagnosis: (b)(6) 2019.
Event or Problem Description
Patient representative reported ¿diagnosed with bia-alcl,¿ pathological markers not provided, patient ¿continues to suffer from mental stress, anxiety, worry, humiliation, fear, concern and other personal ¿ hardship due to the continuous fear of bia alcl,¿ ¿suffered emotional distress, anxiety,¿ ¿loss of quality of life,¿ ¿suffered, or will suffer, painful removal procedures to mitigate the risk of developing bia-alcl, as well as any treatment, therapy, recovery ¿ associated with the removal of the biocell textured breast implants,¿ ¿the potential for the development of bia-alcl, and any condition or symptoms associated with bia-alcl or the prevention of that issue¿ and ¿suffered debilitating physical pain.¿ pathological markers cd30+ and alk- were not provided.Patient representative also reported patient experienced ¿depression¿ and ¿disability;¿ these events are not related to the device.Device was explanted.Affected side is right.

• Brand Name: STYLE 168 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: 10089489
• Report Number: 9617229-2020-09085
• Device Sequence Number: 2438416
• Product Code: FWM
• UDI-Device Identifier: 10888628000926
• UDI-Public: 10888628000926
• Combination Product (Y/N): N
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2020

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: 02/18/2020
• Device Model Number: 168-700
• Device Catalogue Number: 168-700
• Device Lot Number: 2884267
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 05/26/2020
• 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: 56 YR