MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. 3DMAX LIGHT; SURGICAL MESH

Catalog Number 0117311

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Disability (2371)

Event Date 02/20/2016

Event Type  Injury  

Manufacturer Narrative

No lot number has been provided; therefore a review of the manufacturing records and related manufacturing process reviews could not be performed.Adhesions are a known inherent risk of surgery and are listed in the adverse reaction section of the ifu as a possible complication.Multiple attempts have been made to request additional information.At this time, no additional information has been provided.Based on the information available at this time, no conclusions can be made.Should additional information be provided, a supplemental mdr will be submitted.Note - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Remains implanted.

Event Description

The following was reported via maude event report (mw5068837): "bard 3dmax light mesh implanted for inguinal hernia.Constant pain for one year and two months following surgery.Problem was ignored in subsequent visits to surgeon; was told to take large doses of ibuprofen on a constant and ongoing basis.Missed 4 days of work in the last week; visited emergency room; cat scan showing nothing; diagnosis was adhesion due to the mesh implantation; was told to see surgeon who performed hernia surgery.Visited surgeon again, 2017; surgeon has refused to remove mesh-says he can do nothing.Referred to pain doctor for pain medication rather than addressing the problem with implanted mesh.Mesh is still implanted.I am in constant pain.Unknown if i will be able to continue working.I do not want to take opioids for pain; i want the mesh removed and problem resolved.Severe, constant abdominal pain from implant bard 3dmax light left large mesh implant.".

Manufacturer Narrative

The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

• Brand Name: 3DMAX LIGHT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6589314
• MDR Text Key: 75893999
• Report Number: 1213643-2017-00328
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K091659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0117311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2017
• Initial Date FDA Received: 05/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 57 YR
• Patient Weight: 88