MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 110 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	110-330
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	11/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 event of seroma 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: seroma-late and rupture.These are a known potential adverse events addressed in the product labeling.
Event or Problem Description
Patient reported experiencing issues: "fluid build up" and "their implant may be leaking." this record is for the left side.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified to be underweight and an extended opening on the anterior.A visual and microscopic analysis was performed which identified a sharp opening on the posterior due to a surgical impact opening, for the stress mark in the shell.A dimension measurement in the shell was performed which identified the thickness was within specification base on the device analysis the final assessment is: a sharp opening on posterior due to a surgical impact opening.
Event or Problem Description
Device has been explanted.

• Brand Name: STYLE 110 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: 9391686
• Report Number: 9617229-2019-18999
• Device Sequence Number: 2424333
• Product Code: FTR
• UDI-Device Identifier: 10888628002234
• UDI-Public: 10888628002234
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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: 05/19/2020
• Device Model Number: 110-330
• Device Catalogue Number: 110-330
• Device Lot Number: 2760456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 11/29/2019
• Supplement Report FDA Received Date: 03/24/2020
• 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: 55 YR