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

Catalog Number 0115320

Device Problem Folded (2630)

Patient Problems Abdominal Pain (1685); Disability (2371)

Event Type  Injury  

Manufacturer Narrative

The contact indicated hospitalization as an event outcome on the maude event report; however the information provided does not indicate that the patient was hospitalized as a result of the alleged mesh implant.The maude event report did not include contact information, therefore we are unable to request additional event details from the contact.Based on the limited information provided, at this time no conclusion can be made as to the degree to which the mesh implant may be causing or contributing to the patient's reported post implant experience.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be obtained, a supplemental mdr will be submitted.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 (mw 5067181): "patient called to report adverse event involving bard hernia mesh she had implanted in 2014.Patient stated she feels a lot of severe pain in her abdomen since the implantation of the mesh.She said it feels like it's folding when she bends and she doesn't know what to do.Patient stated that the implanting doctor has refused to remove the mesh.Patient lost her insurance so cannot seek a second opinion at this time.Patient said she has so much discomfort in her stomach, and that her bowels have also been affected.She said the pain is terrible at night, and she can feel hard lines and lumps in the pubic area like the mesh is folded up.".

Manufacturer Narrative

The follow-up mdr is being submitted as a result of a retrospective review of davol's mdr files.

• Brand Name: 3DMAX
• 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: 6380207
• MDR Text Key: 69147437
• Report Number: 1213643-2017-00152
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K081010
• 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: 06/20/2017

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 Expiration Date: 06/30/2019
• Device Catalogue Number: 0115320
• Device Lot Number: HUYE1726
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2017
• Initial Date FDA Received: 03/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2014
• 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