MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC; UPSYLON

Model Number M0068318200

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2015

Event Type  malfunction  

Event Description

Mesh was taken from the package and transferred to the tech in a sterile manner.Md placed the mesh in the patient and noted a defect in the mesh.Mesh was removed from the patient and there was no patient injury or patient impact.

• Brand Name: BOSTON SCIENTIFIC
• Type of Device: UPSYLON
• Manufacturer (Section D): BOSTON SCIENTIFIC; 300 boston scientific way; marlborough MA 01752 1234
• MDR Report Key: 5401849
• MDR Text Key: 37336210
• Report Number: MW5059805
• Device Sequence Number: 1
• Product Code: OTO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: M0068318200
• Device Lot Number: C002592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR