MAUDE Adverse Event Report: LIFECELL HP TISSUE MATRIX

Model Number HPTM

Device Problem Insufficient Information (3190)

Patient Problem Staphylococcus Aureus (2058)

Event Date 08/05/2015

Event Type  Injury  

Event Description

Developed a staph infection of either the breast expander or the hptm by lifecell.I noticed in my record that the dermal matrix was in trial.I did not give any permissions to be in a trial.Dermal matrix and implants were removed due to a staph infection (b)(6) 2016.

• Brand Name: HP TISSUE MATRIX
• Type of Device: HP TISSUE MATRIX
• Manufacturer (Section D): LIFECELL
• MDR Report Key: 5707009
• MDR Text Key: 46889453
• Report Number: MW5062726
• Device Sequence Number: 1
• Product Code: OXH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/30/2015
• Device Model Number: HPTM
• Device Catalogue Number: 08161097
• Device Lot Number: UP100005-026
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 71