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

Model Number	68LP-440
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/15/2020
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.Reason for reoperation: deflation.
Event or Problem Description
Healthcare professional reported right side "deflation".Device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: h3, h6.Device evaluation: visual analysis of the returned device identified: fold creases, wear abrasion, linear opening, imprint of patch logo on opposite side of the shell consistent with folded device, observed void >1 mm in non-textured, valve-to shell-bond area.Leak test and microscopic analysis was performed which identified: a linear striated opening on radius side assessed as surgical damage.The fill test inspection was performed, the result is no blockage.Based on the device analysis the final assessment is: - a linear striated opening assessed as surgical damage consist in the use of some surgical tool.- the crease/folding of implant condition that was indicated in the complaint was observed, nevertheless is not considered a workmanship, since the device was explanted.
Event or Problem Description
Healthcare professional reported right side "deflation".Healthcare professional later reported "any creases, and hole on patch side." device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a.2, b.5, b.6, d.6b, d.9, g.2, h.3, h.6.
Event or Problem Description
Healthcare professional later reported "any creases and hole on patch side." 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
• MDR Report Key: 11379183
• Report Number: 9617229-2021-01913
• Device Sequence Number: 3786008
• Product Code: FWM
• UDI-Device Identifier: 10888628000636
• UDI-Public: 10888628000636
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2021

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: 04/17/2023
• Device Model Number: 68LP-440
• Device Catalogue Number: 68LP-440
• Device Lot Number: 3342033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 04/23/2021; 05/24/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 05/20/2021; 06/22/2021
• 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: 66 YR
• Patient Weight: 65