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

Model Number	110-390
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	07/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A review of the device history record has been completed.No deviations or non-conformances noted.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: "rupture" "seroma" "many lymphocytes".
Event or Problem Description
Patient reported left side "rupture".Healthcare professional reported "seroma" and "many lymphocytes." device was explanted.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified a broken shell, white biological tissue in the shell and device found to be underweight.A visual and microscopic analysis was performed which identified a sharp broken on the posterior assessed as a surgical impact opening, for the stress mark in the shell and a wear abrasion.A dimension measurement on the shell was performed which identified the thickness was within specification.Based on the device analysis the final assessment is: a sharp broken on posterior assessed as a surgical impact opening.
Event or Problem Description
Patient reported left side "rupture".Healthcare professional reported "seroma" and "many lymphocytes." device was 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
• MDR Report Key: 12305505
• Report Number: 9617229-2021-49512
• Device Sequence Number: 17358560
• Product Code: FTR
• UDI-Device Identifier: 10888628002258
• UDI-Public: 10888628002258
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2021

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: 12/14/2020
• Device Model Number: 110-390
• Device Catalogue Number: 110-390
• Device Lot Number: 2856722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/29/2021
• 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