MAUDE Adverse Event Report: UNKNOWN PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Device Problem Insufficient Information (3190)

Patient Problem Rupture (2208)

Event Type  Injury  

Event Description

Health professional reported a left side "rupture" of a saline device against 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: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17530703
• MDR Text Key: 321110171
• Report Number: MW5137621
• Device Sequence Number: 1
• Product Code: FWM
• 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: 01/03/2019

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