MAUDE Adverse Event Report: BARD VENTRALIGHT ST MESH

Lot Number HUXB0563

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Diarrhea (1811); Flatus (1865); Cramp(s) (2193); Weight Changes (2607); Constipation (3274)

Event Date 04/23/2013

Event Type  Injury  

Event Description

Reporter stated that she suffered from abdominal pain ever since she had the implant.The pain is on the right hand side where the implant is.She also said there is a bulge about the size of 4 to 5" by the surgery site.She has seen her doctor for a follow up visit several times, and was told the bulge would go away on its own.She went on to say that the bulge has shrunk to 3", however it is still there and it is hard.Her pain was radiating from her abdomen to her chest and then to her lower pelvis.Reporter said the doctors checked everything and did all kinds of tests, such as mri, ct scan, colonoscopy and everything came back negative.Among other things, she is also having constipation, diarrhea, cramps on her legs, edema on her lower limbs and feet, unexplained weight gain, pressure on her abdomen, and cannot have sexual intercourse.Reporter stated that she cannot take pain medication since it makes her feel nauseous.She also had bladder reflux which has been taken care of now.She said the device has been recalled.

• Brand Name: VENTRALIGHT ST MESH
• Type of Device: VENTRALIGHT ST MESH
• Manufacturer (Section D): BARD
• MDR Report Key: 6547330
• MDR Text Key: 74629413
• Report Number: MW5069569
• 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
• Type of Report: Initial
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/01/2015
• Device Lot Number: HUXB0563
• Other Device ID Number: REF: 5954460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 71