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

Catalog Number 0010204

Device Problems Break (1069); Folded (2630); Detachment of Device or Device Component (2907)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Hernia (2240)

Event Date 07/10/2013

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.The medical records provided indicate the patient experienced pain, hernia recurrence and adhesions.Adhesions and recurrence are listed as known possible adverse reactions in the instructions-for-use.It is alleged the ring inside the composix kugel mesh broke, however, the medical records provided do not mention any type of ring break encountered during the explant procedure of the composix kugel mesh in (b)(6) 2013.A legal request made to the doctor on 12/2014 indicates the ring was fractured.Due to not having a sample returned for evaluation the report of ring break and the reason for the alleged ring break can not be determined or confirmed.With the current information available no conclusion can be made.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.The subject product is part of the composix kugel recall.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.Device not returned to manufacturer.

Event Description

The following is based on a review of medical records provided to davol by the patient's attorney: on (b)(6) 2005 - the patient was diagnosed with an incisional hernia and underwent repair of hernia with implant of a davol composix kugel hernia patch.No operative details were provided for this procedure.On ni/ni/ni - patient had breast reconstructive procedure (tram flap) with implant of a non-bard davol mesh.On (b)(6) 2013 - the patient was diagnosed with abdominal wall pain.The patient underwent abdominal wall exploration, removal of the non-bard davol mesh, exploratory laparotomy, removal of the davol composix kugel hernia patch, repair of ventral hernia defect, abdominoplasty and excision of lower abdominal wall masses x2.Per the op report "underneath, there was, again, a large palpable object in the mid epigastric region.There was a small fascial defect over top of it.This was dissected and explored and it was seen that there was a ringed kugel style mesh that was within the abdominal cavity.On further exploration of this piece of mesh, it was found to be partially detached from underneath and folded upon itself.There was some omentum adherent to the underside of the mesh (ck), the mesh (ck) was a ring style oval mesh that was folded in itself and appeared to be pressing directly on to the liver.The entire ringed mesh (ck) was carefully dissected free from adhesions and was subsequently removed." the resulting defect was repaired as a hernia with ethibond sutures.On (b)(6) 2013 - patient had a follow up routine nursing home care visit with indication that the patient was doing well and her abdominal wound was healing.Based on a legal request made to the md in 12/2014, the physician signed a form which indicated the composix kugel ring was fractured.No other information was provided regarding the alleged ring break.

• 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: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 6345841
• MDR Text Key: 67853958
• Report Number: 1213643-2017-00120
• 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: consumer,other
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/21/2017

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: 01/31/2010
• Device Catalogue Number: 0010204
• Device Lot Number: 43APD248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2005
• 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): Required Intervention
• Patient Age: 67 YR