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

Catalog Number 0010201

Device Problems Defective Device (2588); Folded (2630); Torn Material (3024)

Patient Problem Hernia (2240)

Event Date 10/08/2012

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown whether the device may have caused or contributed to the reported event.It is alleged the patient experienced recurrence following implant of the bard/davol composix kugel mesh.Recurrence is listed as possible known adverse reaction in the instructions-for-use.It was also reported that the composix kugel mesh was found "torn and folded on itself." the mesh was not returned for evaluation, therefore the allegation of torn and folded mesh could not be confirmed.We have contacted the initial reporter to request additional information and to request return of the device for evaluation.A manufacturing review was performed and found no evidence of a manufacturing related cause for the alleged event.If additional event and/or evaluation information is obtained, a follow up 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.

Event Description

The following is based on medical records provided to davol by the patient's attorney: (b)(6) 2005 - patient underwent implant of a bard/davol composix kugel hernia patch to repair an incisional hernia from a previous laparoscopic cholecystectomy.On (b)(6) 2005 - patient underwent a laparoscopic paraesophageal/hiatal hernia repair and nissen fundoplication due to a history of gerd.On (b)(6) 2012 - patient underwent a ventral hernia repair with placement of a "6.4 cm circular ventral patch" and partial omentectomy with removal of "foreign body old mesh" (ck).Operative dictation notes the composix kugel was found "torn and folded on itself." the omentum was resected along with the mesh.On (b)(6) 2013 - patient underwent repair of an incarcerated ventral hernia following a motor vehicle accident that caused a bulge above her previous hernia repair site.Operative dictation notes the fascia to have approximately a centimeter defect present noted just above the patient's previous hernia repair where mesh was placed ("6.4cm circular ventral patch).No mesh placed at this time.On (b)(6) 2013 - patient underwent repair of a recurrent incisional hernia (2cm) with drainage of a 10 cm subcutaneous seroma.Operative notes indicate the 2cm hernia was located where the sutures had pulled through the fascia.On (b)(6) 2013 - patient underwent repair of a recurrent incarcerated incisional hernia with placement of non bard/davol strattice mesh and removal of foreign body "old mesh" (6.4 c circular ventral patch).Operative dictation notes the defect to be 5cm in diameter that would not approximate easily so the non bard/strattice mesh was placed.The "old mesh" (6.4cm circular ventral patch) was removed with the hernia sac.On (b)(6) 2015 - patient underwent an incisional herniorrhaphy.Operative dictation notes the hernia to be off to the left of midline and was approx 7cm in diameter.Small bowel was reducible.The defect was closed with sutures.Also noted, the muscle was very attenuated due to the patient's previous obesity.

• 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: 5245909
• MDR Text Key: 32005455
• Report Number: 1213643-2015-00400
• 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
• Type of Report: Initial
• Report Date: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2009
• Device Catalogue Number: 0010201
• Device Lot Number: 43HOD536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2004
• 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: 42 YR