MAUDE Adverse Event Report: UNKNOWN EXPANDER, BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Through journal article "an unusual case of bia-alcl associated with prolonged/comp biocell-textured expander, followed by smooth round breast implant exposure, and con use of adalimumab" the authors report a series of events occurring against a non-allergan the device has been explanted and not replaced.Affected side is right.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: EXPANDER, BREAST IMPLANT
• Type of Device: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17525442
• MDR Text Key: 321158814
• Report Number: MW5132383
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Treatment: EXPANDER, SKIN,