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

Catalog Number 0010303

Device Problem Device Expiration Issue (1216)

Patient Problems Abdominal Pain (1685); Pain (1994); Hernia (2240)

Event Type  Injury  

Event Description

The following was reported to davol via maude event report (b)(4): "patient has undergone several treatments and procedures due to cancer.On 2013, patient had surgery for hernia repair.During implantation, pt experienced horrific pain.After surgery, the surgeon and hospital administration came in to the patient's room to notify her that the mesh that was just implanted was expired.Surgeon states that he noticed it in the operating room after implantation and decided to leave it in.Patient is very concerned about having an expired product inside of her, which is now failing.Her small intestines are poking through the mesh and her stomach looks hilly.Patient has spent several weeks in the hospital due to complications with mesh.Surgeon states that the mesh has to be removed but, patient has been very sick while undergoing chemotherapy and will not be able to have mesh removed until her chemo treatments are done.Patient states that the revision surgery scares her because the incision will have to start from the top of her breast bone all the way down her abdomen.Patient is requesting any information or research on expired mesh.".

Manufacturer Narrative

Based on the limited information that has been provided, at this time, no conclusion can be made as to the degree to which the mesh implant may have caused or contributed to the alleged patient outcome.Based on the lot number provided the expiry date was 07/2013 and as alleged the mesh implant date was (b)(6) 2013, three months after the expiry date.A review of the manufacturing records showed that the lot was manufactured to specification.As reported it is possible the patient has experienced a hernia recurrence.Recurrence is identified in the adverse reaction section of the ifu as a possible complication.It is unlikely that the device being implanted after its expiration period would result in a hernia recurrence.If additional information is obtained, a follow up mdr will be submitted.The information provided by bard represents all of the known information at this time.Contact information was not included on the medwatch report therefore we are currently unable to request additional information for the reporter.

Manufacturer Narrative

Not returned to manufacturer.

• Brand Name: MESH - VENTRALEX
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 4895805
• MDR Text Key: 6536344
• Report Number: 1213643-2015-00230
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K021736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/15/2015

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: 07/31/2013
• Device Catalogue Number: 0010303
• Device Lot Number: HUSG0719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/15/2015
• Initial Date FDA Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/15/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention