MAUDE Adverse Event Report: ALLERGAN COSTA RICA UNK MAMMARY IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number UNK MAMMARY IMPLANT

Device Problems Device Appears to Trigger Rejection (1524); No Apparent Adverse Event (3189)

Patient Problems Capsular Contracture (1761); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2022

Event Type  Injury  

Event Description

Healthcare professional reported left side capsular contracture, baker's grade iii-iv.The device has been explanted.

Manufacturer Narrative

Continued h.6.(health effect - impact code): f2203.The event of capsular contracture 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 product, patient details, implanting/explanting physician and facility information, device return has been requested.No additional information is available at this time.Reason for reoperation: capsular contracture.

Manufacturer Narrative

Additional, changed, and/or corrected data: b5, h6.

Event Description

It has been determined that the device associated with this complaint is not pma approved.This record is no longer reportable to fda and will be un-reported.

• Brand Name: UNK MAMMARY IMPLANT
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): ALLERGAN COSTA RICA; CS
• Manufacturer (Section G): ALLERGAN COSTA RICA; CS
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 17984099
• MDR Text Key: 326240984
• Report Number: 9617229-2023-17541
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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 Assistant
• Type of Report: Initial,Followup
• Report Date: 11/25/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK MAMMARY IMPLANT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 23 YR
• Patient Sex: Female