MAUDE Adverse Event Report: C. R. BARD, INC. BARD VENTRALIGHT MODEL 5955790; MESH, SURGICAL POLYMERIC

Model Number HIUW5884

Device Problem Migration (4003)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 05/25/2019

Event Type  malfunction  

Event Description

When i went to the bathroom one day i had a terrible pain when i passed my poop.I noticed before i flushed that there was huge mass and a tube that fell out of me with a lot of blood.I went to the hosp with a lot of pain in my abdomen.I had a ct scan and the dr informed me that my mesh wasn't there.I have ct records that shows a mesh and revision mesh from a hysterectomy after the hernia mesh was implanted 2 years and 11 months before.It was a bard ventralight and was told by some comsol employees that it should stay in me for at least 25 years before any problems should occur.I have no phone at this time so please email me at (b)(6); will send picture soon.Cannot download files.Fda safety report id# (b)(4).

• Brand Name: BARD VENTRALIGHT MODEL 5955790
• Type of Device: MESH, SURGICAL POLYMERIC
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 8735002
• MDR Text Key: 149357334
• Report Number: MW5087600
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2014
• Device Model Number: HIUW5884
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 100 YR
• Patient Weight: 2