MAUDE Adverse Event Report: UNKNOWN MANUFACTURER UNK MAMMARY IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number UNK MAMMARY IMPLANT

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Injury (2348)

Event Date 01/01/2010

Event Type  Injury  

Manufacturer Narrative

The event of device migration is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.The reason for reoperation: ¿left breast implant had migrated to her arm pit, and that she had no cleavage".Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.

Event Description

Patient representative reported ¿left breast implant had migrated to her arm pit, and that she had no cleavage,¿ and alleges patient ¿suffered bodily injury and resulting pain and suffering, mental anguish, disability, disfigurement, and loss of the capacity for the enjoyment of life.The losses are permanent or continuing in nature, and she will suffer them in the future¿.Device has been explanted.Manufacturer of the device is unknown.This record is for the left side.

• Brand Name: UNK MAMMARY IMPLANT
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): UNKNOWN MANUFACTURER
• Manufacturer (Section G): UNKNOWN MANUFACTURER
• Manufacturer Contact: michelle burgess ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 8775388
• MDR Text Key: 150537514
• Report Number: 9617229-2019-08391
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• PMA/PMN Number: P990074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• 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?: No
• Date Manufacturer Received: 05/02/2019
• 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: 34 YR