MAUDE Adverse Event Report: LIFECELL STRATTICE

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 08/11/2016

Event Type  Injury  

Event Description

(b)(4).Bleeding, haematoma on my breast.

• Brand Name: STRATTICE
• Manufacturer (Section D): LIFECELL
• MDR Report Key: 5893095
• MDR Text Key: 52632112
• Report Number: MW5064229
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59.000 YR