MAUDE Adverse Event Report: ALLERGEN STRATIS MESH

Device Problem Hole In Material (1293)

Patient Problems Erythema (1840); Fever (1858)

Event Date 11/25/2015

Event Type  Injury  

Event Description

Redness, fever, mesh stratis used in breast reconstruction, then hole appeared in implants, and multiple surgeries through (b)(6) 2016.

• Brand Name: STRATIS MESH
• Type of Device: STRATIS MESH
• Manufacturer (Section D): ALLERGEN
• MDR Report Key: 5690697
• MDR Text Key: 46363613
• Report Number: MW5062537
• Device Sequence Number: 1
• Product Code: FTL
• 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: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 42 YR
• Patient Weight: 65