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

Catalog Number 0010204

Device Problems Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Fistula (1862); Foreign Body Reaction (1868); Inflammation (1932); Seroma (2069); Disability (2371)

Event Date 07/09/2010

Event Type  Injury  

Manufacturer Narrative

There is no connection that can be made at this time between the reported post-operative complications and any problem with the bard/davol device used to treat the patient.The sample was not returned for evaluation.Based on the limited information provided at this time, no conclusions can be made.Inflammation is identified in the adverse reaction section of the instructions-for-use as a possible complication.No lot number was provided therefore a review of the manufacturing records is not possible at this time.Based on the date of implant the subject product is part of the composix kugel recall initiated on (b)(4) 2005.Should additional information be provided a supplemental emdr will be submitted.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Not returned.

Event Description

The following was alleged by the patient's attorney:on (b)(6) 2006: the patient underwent a hernia surgery for a ventral hernia and umbilical hernia.As reported, the patient's hernia was repaired with a bard/davol 11.4cm x 11.4cm oval kugel patch, product code 0010204.It is alleged that sometime after placement the device malfunctioned by, inter alia, contracting, suffering degradation, and causing an intense foreign body and inflammatory response.It is alleged that as a result of these failures, the patient has suffered severe injuries, required substantial medical care, has suffered and will continue to suffer physical pain.

Event Description

The following was alleged by the patient's attorney: (b)(6) 2006: the patient underwent a hernia surgery for a ventral hernia and umbilical hernia.As reported, the patient's hernia was repaired with a bard/davol 11.4cm x 11.4cm oval kugel patch, product code 0010204.It is alleged that sometime after placement the device malfunctioned by, inter alia, contracting, suffering degradation, and causing an intense foreign body and inflammatory response.It is alleged that as a result of these failures, the patient has suffered severe injuries, required substantial medical care, has suffered and will continue to suffer physical pain.Addendum per additional information provided: (b)(6) 2006 - patient was diagnosed with incarcerated ventral recurrent hernia and umbilical hernia thereby underwent open repair with the implant of composix kugel mesh.Per operative notes, ¿a large hernia sac was mobilized and reduced from the abdominal wall.There was evidence of old repair could be seen and an umbilical hernia was also identified and was then divided.A composix mesh was then placed to the anterior abdominal wall and tacked.¿ (b)(6) 2009 - patient was diagnosed with infection of ventral hernia repair thereby underwent repair with incision and drainage of a small abscess of an old graft.Per operative notes, ¿a small fistula tract was excised down to an area of frank purulence containing pus.¿ (b)(6) 2010 - patient was diagnosed with infected bard composix mesh patch thereby underwent repair with removal of patch.Per operative notes, ¿the graft was noted to be turned under superiorly with a lip of the mesh adhered to a loop of bowel and part of the mesentery, this was dissected off.Encounter an isolated pocket of infected fluid that represented the central portion of the mesh and was then excised.A biologic mesh was placed and sutured.¿ attorney alleges that the patient had abscess, adhesions, infection, mesh migration, mesh shrinkage, pain, hernia recurrence, seroma and emotional injuries.It was also alleged that the chronic draining sinus tract in the middle of the previously placed ventral hernia patch.

Manufacturer Narrative

There is no connection that can be made at this time between the reported post-operative complications and any problem with the bard/davol device used to treat the patient.The sample was not returned for evaluation.Based on the limited information provided at this time, no conclusions can be made.Inflammation is identified in the adverse reaction section of the instructions-for-use as a possible complication.No lot number was provided therefore a review of the manufacturing records is not possible at this time.Based on the date of implant the subject product is part of the composix kugel recall initiated on december 2005.Addendum: this supplemental emdr is submitted to document additional information provided: based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per medical records review, about 4 years 2 months post implant of composix kugel mesh patient was diagnosed with infection, fistula, seroma, abscess and adhesions thereby underwent removal of mesh.The instructions-for-use supplied with the device lists seroma, fistula and adhesions as possible complications.The warnings section in ifu states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the mesh." note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text: device not returned.

• Brand Name: MESH - 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 7155276
• MDR Text Key: 96109976
• Report Number: 1213643-2017-01148
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2010
• Device Catalogue Number: 0010204
• Device Lot Number: 43HPD338
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0761-06
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 91 KG