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

Catalog Number 0010208

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

Patient Problems Fistula (1862); Unspecified Infection (1930); Internal Organ Perforation (1987)

Event Date 07/11/2010

Event Type  Injury  

Manufacturer Narrative

At this time it is unknown to what extent the bard/davol composix kugel (device #2) device may have caused or contributed to the events as alleged by the patient¿s attorney.The information provided alleges as a result of the defective nature of the mesh, the patient suffered severe complications following the surgery, including small bowel obstruction, abscess and infection.The patient underwent abdominal wound incision and drainage with wound vac placement and excision of the bard/davol composix kugel.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." no lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Based on the limited information provided at this time, no conclusions can be made.This emdr represents the bard/davol composix kugel (device #2).An additional emdr was submitted to represent the bard/davol bard flat mesh (device #1) and bard/davol ventralight st (device #3).Should additional information be provided, a supplemental emdr will be submitted.Not returned.

Event Description

The following was alleged by the patient's attorney which includes the medical records, patient fact sheet and general patient outcome allegations: on (b)(6) 2006: the patient underwent a pubovaginal sling procedure with implant of a non bard/davol ¿monarc¿ (ams) mesh sling.On (b)(6) 2009: the patient was diagnosed with vaginal vault prolapse with recurrent urinary tract infections and underwent a robotic sacrocolpopexy with implant of a bard/davol bard flat mesh (device #1).On (b)(6) 2009: the patient failed conservative therapy for a small bowel obstruction.Patient underwent an exploratory laparotomy with a small bowel resection.On (b)(6) 2009, (b)(6) 2009 and (b)(6) 2009: the patient had f/u office visits regarding post op wound infection/dehiscence.On (b)(6) 2009: the patient had chronic abdominal non healing wound from previous surgery on (b)(6) 2009.After several months of conservative treatment patient underwent closure of abdominal wound.On (b)(6) 2010: the patient was diagnosed with incisional hernia and underwent repair with implant of a bard/davol composix kugel (device #2).On (b)(6) 2010: the patient presented to the hospital with abdominal pain and was admitted to hospital with partial small bowel obstruction and incisional hematoma.Patient was treated conservatively and discharged after the obstruction resolved.On (b)(6) 2010: the patient was diagnosed with abdominal wall abscess with infected abdominal mesh (ck) and underwent abdominal wound incision and drainage with wound vac placement and excision of the bard/davol composix kugel ( device #2).On (b)(6) 2011: the patient was diagnosed with recurrent incisional hernia and underwent incisional hernia repair with implant of a bard/davol ventralight st(device #3) with using a bard/davol sorbafix fixation device.On (b)(6) 2011: the patient was diagnosed with abdominal wound healing failure, hematoma and underwent closure of abdominal wound.Alleged outcomes attributed to device of pain, erosion, infection, urinary problems, bowel problems, organ perforation (colon), fistulae, recurrence, neuromuscular problems, vaginal scarring, other: ((b)(6) 2009 back pain, blood in urine (b)(6) 2011, hernia (b)(6) 2011, hematoma (b)(6) 2009- (b)(6) 2010, pelvic adhesion.).

• 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: roxanne tidwell ; 100 crossings blvd.; warwick, RI 02886 ; 8015652659
• MDR Report Key: 8002680
• MDR Text Key: 124956889
• Report Number: 1213643-2018-03704
• 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: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0010208
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2018
• 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): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 83