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

Model Number 68-360

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 05/03/2023

Event Type  Injury  

Event Description

Healthcare professional reported right side "deflation during implant surgery" and "during the surgery the valve disconnected".Device not implanted.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformities 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: valve leaked during implant surgery with deflation.

Manufacturer Narrative

Device evaluation: based on the device analysis the final assessment is: deflation/valve leak and/or damage: not observed.Additional observations: ¿ white particles inside of the device.¿ crease flat observed.No further actions are required as the device was implanted.

Event Description

Healthcare professional reported right side "deflation during implant surgery" and "during the surgery the valve disconnected".Device not implanted.

• Brand Name: STYLE 68 SALINE FILLED BREAST IMPLANT
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• 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: 17066380
• MDR Text Key: 316659929
• Report Number: 9617229-2023-09513
• Device Sequence Number: 1
• Product Code: FWM
• UDI-Device Identifier: 10888628000230
• UDI-Public: 10888628000230
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P990074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 68-360
• Device Catalogue Number: 68-360
• Device Lot Number: 3654093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2022
• 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 Age: 32 YR
• Patient Sex: Female
• Patient Weight: 60 KG