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

Catalog Number 0010202

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

Patient Problems Abscess (1690); Unspecified Infection (1930); Internal Organ Perforation (1987)

Event Date 07/25/2018

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made to what extent the bard/davol composix kugelmay have caused or contributed to the reported event.The attorney alleges the patient underwent an additional surgeries for an infected mesh, "a perforated colon" and adhesions.Adhesions is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.No medical records have been provided.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 and found that the lot was manufactured to specification.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.Not returned.

Event Description

The following was alleged by the patient's attorney: on (b)(6) 2010: the patient had a kugel patch implanted to repair a ventral hernia defect.On (b)(6) 2017: the patient presented to the emergency room because she was experiencing abdominal pain, fever symptoms, hematuria, chest pain and decreased appetite.She was admitted to the hospital.On (b)(6) 2017: while still hospitalized,the patient underwent surgery for removal of the infected mesh, small bowel resection, reanastomosis, drainage of abdominal abscesses, sigmoid colon resection, omentectomy and a bilateral salpingo-oophorectomy.The patient was hospitalized from (b)(6) 2017 until her discharge on (b)(6) 2017.Patient suffered severe and permanent injuries.On (b)(6) 2017, patient continued to experience abdominal pain and presented emergency room for abdominal pain and fever symptoms and was admitted to the hospital.On (b)(6) 2017: the patient underwent surgery for a perforated colon, drainage of multiple abscesses, extensive lysis of adhesions lasting over one and one-half hours, complex wound closure, and left colectomy and colostomy.The patient was discharged from the hospital on (b)(6) 2017.Patient suffered severe and permanent injuries.On (b)(6) 2018: the patient underwent surgery for a descending left colon resection, colostomy closure, mobilization of splenic flexure, component separation, repair of midline ventral hernia, repair of stomal hernia and an appendectomy.On (b)(6) 2018: patient was discharged.Patient suffered severe and permanent injuries.The patient has suffered and will continue to suffer physical pain as well as mental anguish.The product implanted in patient failed to reasonably perform as intended.It caused serious injury and had to be removed via invasive surgery and necessitated additional invasive surgeries to repair the hernia that the product was initially implanted to treat.The patient has been injured, sustained past and future, severe and permanent pain, suffering, anxiety, depression, disability, impairment due to the alleged defective kugel patch.

• Brand Name: COMPOSIX KUGEL
• 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: 8075104
• MDR Text Key: 127284197
• Report Number: 1213643-2018-04051
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061314
• 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: 11/15/2018

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: 12/28/2013
• Device Catalogue Number: 0010202
• Device Lot Number: HUSL1391
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2018
• Initial Date FDA Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2008
• 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