MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA FULLPROF 560CC SSZ US; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number SSZ-F560

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2023

Event Type  Injury  

Event Description

Healthcare professional reported "breast sizer was opened and st noticed that the package was not completely sealed and therefore not sterile".The device was not implanted.

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.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The reason for reoperation: breach of sterile barrier seal.

Manufacturer Narrative

Device evaluation: based on the device analysis grid, the assessments of the complaint are: breach of sterile barrier seal: unable to observer since the thermoform is open.No additional observations are performed.No further actions are required as no manufacturing issues are observed.A review of the device history record has been completed.No deviations or non-conformances noted.The review of the documentation associated to the manufacturing process indicates that all devices with lot number 3573213 were released in accordance with abbvie¿s procedures and were no defects/problems/issues found in the documents or in the personnel training related to the reported event.Additionally, no er/ ncr(s) were identified during the investigation associated with this lot and the complaint.According to the complaint review the packages has not been received for analysis in the device analysis laboratory yet.A review of the current risk documents pfmea-bi pkg and lblg (v11.0) was performed and the event of compromised sterility is a known event, for which manufacturing process controls and inspections are stablished to reduce the incidence of this defect.Per evaluation performed in this investigation and appendix c of procedure qpp07-01-002 rev 21.0, this case is not confirmed as high impact complaint, and no further actions are required at this time.During the trend review of all breach of sterile barrier seal complaints for gel breast implant for the period of oct 2021 through sep2023, was noted one outlier in jun 2022.The additional analysis performed shows all that results met the acceptance criteria and no issues, deviations or non-conformances were found which could be associated to the breach of sterile barrier seal event, so, no additional actions are deemed required at this time.The issue with breach of sterile barrier seal will continue to be monitored and corrective action taken in the future if deemed appropriate.Additional, changed, and/or corrected data: d9, e1, h3, h6.

Event Description

Healthcare professional reported "breast sizer was opened and st noticed that the package was not completely sealed and therefore not sterile." the device was not implanted.

• Brand Name: NATRELLE INSPIRA FULLPROF 560CC SSZ US
• Type of Device: SIZER, MAMMARY, BREAST IMPLANT VOLUME
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 17989459
• MDR Text Key: 326319479
• Report Number: 9617229-2023-17229
• Device Sequence Number: 1
• Product Code: MRD
• UDI-Device Identifier: 10888628045132
• UDI-Public: 10888628045132
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K831566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SSZ-F560
• Device Lot Number: 3573213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female