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

Catalog Number 0113810

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

Patient Problems Unspecified Infection (1930); Disability (2371); 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 kugel may have caused or contributed to the reported event.To date no medical records have been provided.The attorney alleges the patient underwent an additional surgery to treat a "reccurrent" hernia.Recurrence is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.In addition the patient has an open wound and infection.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.¿ a review of the manufacturing records was performed as well as a sterilization process review and found that the lot was manufactured to specification.No sample has been returned for evaluation.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol composix mesh (device #2).An additional emdr was submitted to represent the bard/davol composix kugel (device #1).Note: not returned.

Event Description

The following was alleged by the patient's attorney: on (b)(6) 2010:the patient underwent repair of an incarcerated incisional hernia.The patient was implanted with a bard/davol bard composix kugel (device #1).The patient suffered from chronic pain in her lower abdomen, constipation, an open wound that had trouble healing, and a recurrent hernia.On (b)(6) 2012: the patient underwent repair of a recurrent incisional hernia.It is alleged that the patient was implanted with a bard/davol composix mesh (device #2).The patient began to suffer chronic pain in her lower abdomen and constipation.The patient had an open wound that had trouble healing, and she required wound vac care to treat the incision.It is alleged that the patient has suffered from the open wound since 2012 and has had to continually treat seepages with bandages.The patient has also had to deal with infections related to the incision.The patient continues to experience these complications related to the bard/davol hernia mesh and will continue to suffer from them in the future.The patient's hernia mesh complications cause her pain and suffering, and physical impairment.It is alleged that the polypropylene surgical mesh bard/davol composix kugel (device #1) / bard/davol composix mesh ( device #2)) is defective.The patient has suffered and will continue to suffer permanent pain and suffering and disfigurement.It is alleged that the patient has suffered, sustained and incurred, and in reasonable medical probability will continue to suffer, sustain and incur the following injuries and damages, among others: physical pain, mental anguish, disfigurement, physical impairment, and medical care and treatment.

• 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: 8006613
• MDR Text Key: 125045351
• Report Number: 1213643-2018-03718
• 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: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2012
• Device Catalogue Number: 0113810
• Device Lot Number: HURG0388
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2007
• 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