MAUDE Adverse Event Report: BARD BARD VENTRALIGHT ECHO MESH

Lot Number HUBS0711

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 09/05/2017

Event Type  Injury  

Event Description

Pt has mesh put in to support an inguinal hernia on (b)(6)2017.Subsequently had abdominal pain.On (b)(6)2017, he was taken back to surgery for an exploratory lap.The surgeon found the mesh adhered to the bowel with subsequent partial bowel removal.The mesh was disintegrating on the instruments.He was transferred to icu on a ventilator and will return to surgery for flushing of his abdominal cavity.

• Brand Name: BARD VENTRALIGHT ECHO MESH
• Type of Device: MESH
• Manufacturer (Section D): BARD
• MDR Report Key: 6852942
• MDR Text Key: 85593775
• Report Number: 6852942
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/28/2019
• Device Lot Number: HUBS0711
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/05/2017
• Distributor Facility Aware Date: 09/05/2017
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR