MAUDE Adverse Event Report: BARD VENTRALIGHT ST MESH WITH PS ECHO PS POSITIONING SYSTEM

Lot Number HUAR2061

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2016

Event Type  malfunction  

Event Description

During the implantation of a bard ventralight st mesh, one of the pieces of the positioning device broke off and fell apart inside of the patient's body.All pieces of the device were found and retrieved.The patient was not harmed.The mesh and all pieces were retrieved and was returned to the company.

• Brand Name: VENTRALIGHT ST MESH WITH PS ECHO PS POSITIONING SYSTEM
• Type of Device: MESH
• Manufacturer (Section D): BARD; warwick RI 02886
• MDR Report Key: 5878279
• MDR Text Key: 52288318
• Report Number: MW5064093
• 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: Other
• Type of Report: Initial
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/18/2018
• Device Lot Number: HUAR2061
• Other Device ID Number: 00801741031717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2016
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 58