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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Capsular Contracture (1761); Failure of Implant (1924)

Event Type  Injury  

Event Description

Healthcare professional reported a left side capsular contracture baker grade iii of a non- allergan device.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BREAST IMPLANT (LEFT)
• Type of Device: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17488523
• MDR Text Key: 320692254
• Report Number: MW5121222
• 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: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1