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

Model Number 0123810

Device Problems Defective Device (2588); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Ischemia (1942); Pain (1994); Scar Tissue (2060); Seroma (2069); Hernia (2240); Disability (2371); Fibrosis (3167)

Event Date 06/23/2010

Event Type  Injury  

Manufacturer Narrative

To date, limited information has been provided.Based on the limited information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.Recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the ifu as a possible complication.Review of the device history records found lot was manufactured to specification.No anomalies identified.If additional information is obtained, a supplemental mdr 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

It is alleged by the patients attorney that on (b)(6) 2007, the patient underwent surgery for repair of an incisional hernia.As reported, a bard/davol composix e/x hernia patch mesh, reference number (b)(4), lot number 43aqd352 was implanted to repair the hernia defect.It is alleged that several years later on (b)(6) 2010, the patient underwent an additional surgery for a recurrent hernia.As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective composix e/x hernia patch.

Manufacturer Narrative

Addendum to the previous report.This supplemental emdr is being sent to indicate that there was no explant of the composix mesh ex device as previously reported.It is unknown if the device was explanted during the second procedure.

Event Description

It is alleged by the patients attorney that on (b)(6) 2007, the patient underwent surgery for repair of an incisional hernia.As reported, a bard/davol composix e/x hernia patch mesh, reference number (b)(4), lot number 43aqd352 was implanted to repair the hernia defect.It is alleged that several years later on (b)(6) 2010, the patient underwent an additional surgery for a recurrent hernia.As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective composix e/x hernia patch.

Manufacturer Narrative

To date, limited information has been provided.Based on the limited information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.Recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the ifu as a possible complication.Review of the device history records found lot was manufactured to specification.No anomalies identified.If additional information is obtained, a supplemental mdr will be submitted.Addendum #1: this supplemental emdr is being sent to indicate that there was no explant of the composix mesh ex device as previously reported.It is unknown if the device was explanted during the second procedure.Addendum #2: h11: this supplemental emdr is submitted to document additional information provided and to correct the manufacturing date.Based on the available information, there is no change to the initial determination, no conclusion can be made.Per the medical records review, about 3 years 2 months post implant of composix e/x mesh, this obese patient was diagnosed with hernia recurrence, ischemia, bowel strangulation, seroma, adhesions, fibrosis and scar tissue thereby underwent repair procedure.The instructions-for-use supplied with the device lists seroma and adhesions as possible complications.This supplemental emdr represents composix mesh e/x (device #1).An additional emdr was submitted to represent kugel patch (device #2).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.

Event Description

It is alleged by the patients attorney that on (b)(6) 2007, the patient underwent surgery for repair of an incisional hernia.As reported, a bard/davol composix e/x hernia patch mesh, reference number (b)(4), lot number 43aqd352 was implanted to repair the hernia defect.It is alleged that several years later on (b)(6) 2010, the patient underwent an additional surgery for a recurrent hernia.As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective composix e/x hernia patch.Addendum per additional information provided: (b)(6) 2007 - patient was diagnosed with multiple incisional hernias thereby underwent open repair with the implant of composix e/x mesh (device #1).Per operative notes, "the hernia sac was reduced and adhesions were lysed.A composix e/x mesh (device #1) was placed in the abdomen and sutured it to the anterior abdominal wall." (b)(6) 2010 - patient was diagnosed with recurrent ventral incisional hernia with strangulated small bowel thereby underwent repair with the implant of kugel patch (device #2).Per operative notes, "two additional ventral hernias were found below the recurrent ventral incisional hernia, strangulated and the clear serous fluid was evacuated.Further exploration revealed the fascia to be widely separated and joined with mesh (device #1) superior to the recurrent ventral incisional hernia.The defect was opened slightly, reduced small bowel which was dusky and ischemic.There were some chronic adhesions of one portion of the small bowel to the hernia sac.An oval kugel composite mesh (device #2) was then placed and secured to the fascia.¿ (b)(6) 2011- patient underwent laparoscopic cholecystectomy repair.(b)(6) 2013 - patient had painful bulge at the upper end of a long midline incision and was diagnosed with recurrent incisional hernia thereby underwent repair.Per operative notes, "fibrotic scar tissue was encountered.Inferiorly, the defect was dissected out down to the level of the previously placed mesh from his prior incisional herniorrhaphies.A piece of synthetic mesh was placed then sub-fascially and sutured." attorney alleges that patient had nerve damage, bowel removal, hernia recurrence, pain and emotional injuries.

• Brand Name: COMPOSIX MESH E/X
• 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: 7142549
• MDR Text Key: 95630028
• Report Number: 1213643-2017-01098
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031212
• UDI-Public: (01)00801741031212
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2023

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: 01/28/2011
• Device Model Number: 0123810
• Device Catalogue Number: 0123810
• Device Lot Number: 43AQD352
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 07/27/2018; 12/11/2023
• Supplement Dates FDA Received: 08/03/2018; 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2006
• 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): Disability; Required Intervention; Life Threatening
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 133 KG