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

Catalog Number 0010201

Device Problem Obstruction of Flow (2423)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Nausea (1970); Scar Tissue (2060); Vomiting (2144); Abdominal Distention (2601)

Event Date 07/31/2013

Event Type  Injury  

Event Description

The following is based off a review of the patient's med records provided to davol by the patient's atty: this is a patient with a surgical history significant for bilateral inguinal hernia repairs and one previous mid abdominal hernia repair which was repaired primarily with no mesh.On (b)(6) 2006, the patient underwent repair of a ventral hernia using a bard/davol composix kugel hernia patch and a non-bard / non-davol tracking device.Operative dictation notes adhesions to the existing hernia repair and defect with a large amount of tissue within the defect.These adhesions were taken down and the composix kugel patch was placed in the abdomen through the old scar.On (b)(6) 2013, patient presented to the er with symptoms of nausea, vomiting, abdominal pain, and distention.A ct scan and bowel series indicated a small bowel obstruction.On (b)(6) 2013, the patient underwent an exploratory laparotomy to repair the obstruction.During this procedure, the composix kugel patch "mesh" was noted to have been densely scarred to the bowel, which was the cause of the obstructions and the mesh had to be removed with the bowel.

Manufacturer Narrative

A sample was not returned and no conclusions can be made at this time.It is alleged that the patient suffered from adhesions and infection.Both adhesions and infection are known possible adverse reactions listed in the ifu.We have contacted the initial reporter to request additional info and to request return of the device for eval.A mfg review was performed and found no evidence of a mfg related cause for the alleged event.If additional event and/or eval info is obtained, a follow up mdr will be submitted.

• Brand Name: MESH - COMPOSIX KUGEL
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; warwick RI
• Manufacturer (Section G): BARD SHANNON LTD; san geronimo industrial park; lot #1 road #3 km 79.7; humacao PR 00791
• Manufacturer Contact: steven figueroa ; 100 crossings blvd; warwick, RI 02886 ; 8005566756
• MDR Report Key: 4071983
• MDR Text Key: 20785482
• Report Number: 1213643-2014-00271
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2010
• Device Catalogue Number: 0010201
• Device Lot Number: 43JPD466
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2005
• 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; Disability
• Patient Weight: 104