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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/29/2019
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 pain 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: pain.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported left side "breast implant illness symptoms, bilateral sharp shooting pains around nipples, joint pain in hands and wrist, dry eyes, vision changes, abdominal bloating, fatigue, and anxiety." the device was 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: 8946707
• Report Number: 9617229-2019-13089
• Device Sequence Number: 311199
• Product Code: FWM
• UDI-Device Identifier: 10888628000537
• UDI-Public: 10888628000537
• Combination Product (Y/N): N
• Initial Reporter State: MA
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/29/2019

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: 12/05/2018
• Device Catalogue Number: 68LP-175
• Device Lot Number: 2688359
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/29/2019
• 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