MAUDE Adverse Event Report: C.R. BARD/DAVOL BARD SURGICAL MESH; VENTRALEX OVAL MESH

Device Problem Insufficient Information (3190)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Internal Organ Perforation (1987); Pain (1994)

Event Date 10/22/2014

Event Type  Injury  

Event Description

Mesh was placed on (b)(6) 2014.From that time, patient has been hospitalized 5 times with various infections requiring cleaning.On (b)(6)2015 his abdomen "exploded".Blood traveled over two feet into the air.Paramedics were called and they could not cease the hemorrhage.Subsequently, patient was transported to (b)(6) hospital.He lost approx 3 liters of blood requiring a transfusion.The infection caused by the mesh bore a hole in his abdomen which caused the "explosion".Two doctors indicated to spouse the mesh was removed.Since then, patient was hospitalized three additional times.Once in (b)(6) 2016 and currently.Patient had another surgery to remove the mesh.The doctor found two infections and a hole in his colon.Current prognosis is unknown.Patient has had pain and suffering and has become an invalid in his golden years.His quality of life is tremendously decreased.Wife is requesting that the product be pulled off of the market.

• Brand Name: BARD SURGICAL MESH
• Type of Device: VENTRALEX OVAL MESH
• Manufacturer (Section D): C.R. BARD/DAVOL
• MDR Report Key: 5636661
• MDR Text Key: 44697347
• Report Number: MW5062110
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 73 YR
• Patient Weight: 106