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

Catalog Number UNKAA018

Device Problems Defective Device (2588); Insufficient Information (3190)

Patient Problems Disability (2371); Impaired Healing (2378); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made to what extent the bard/davol composix mesh device may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.Regarding infection the warning section of the instructions-for-use states, ¿if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis.¿ information is limited at this time.Should additional information be provided a supplemental emdr will be submitted.Note: not returned.

Event Description

The following was alleged by the patient's attorney: (b)(6) 2013:the patient was diagnosed with a ventral hernia.On (b)(6) 2013:the patient underwent ventral hernia repair with an unspecified bard/davol composix product.In the months following and continuously to this day, patient continued to have an open wound and continues to experience chronic abdominal pain, and other medical issues including but not limited to: repeated infections in the mesh implant area which he currently is seeking additional medical treatments for.The patient was caused and in the future will be caused to suffer severe personal injuries, pain and suffering, and other damages.The patient has experienced mental and physical pain and suffering has sustained permanent injury, has undergone medical treatment and/or corrective surgery and hospitalization, and other damages due to the alleged defective composix bard mesh.

• Brand Name: COMPOSIX MESH
• 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: jan ling ; 100 crossings blvd.; warwick, RI 02886 ; 8015652663
• MDR Report Key: 8148197
• MDR Text Key: 129876984
• Report Number: 1213643-2018-04539
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA018
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2018
• 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): Hospitalization; Required Intervention; Disability