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

Catalog Number 0010202

Device Problems Folded (2630); Detachment of Device or Device Component (2907); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Scarring (2061); Swelling (2091); Hernia (2240)

Event Date 05/19/2015

Event Type  Injury  

Event Description

The following is based off a review of the patient's medical records provided to davol by the patient's attorney: on (b)(6) 2008 the patient was implanted with a bard/davol composix kugel mesh patch during a hernia repair surgery.On (b)(6) 2009 the patient underwent explant of the composix kugel patch and implant of another composix kugel patch to repair a recurrent incisional hernia.On (b)(6) 2014 patient had a surgeon consult with complaints of a "lump in the mid abdomen." per the md consultation note, "abdomen has a midline vertical scar around the umbilicus and the fascial defect feels to be about 2-3 inches at most.I can feel some clumped up mesh underneath." per the assessment of the md, the patient was diagnosed with a "recurrent ventral hernia." the md suggests a laparoscopic repair but the patient stated "she is not ready to prepare for surgery yet and will let him know.".

Manufacturer Narrative

Currently, it is unknown whether the device may have caused or contributed to the any reported events.Without a lot number a review of the manufacturing records could not be conducted.Based off the information provided the patient suffered from recurrence.Recurrence is listed as a known adverse reaction in the instructions-for-use.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.See mdr 1213643-2014-00330 for information related to the composix kugel mesh implanted on (b)(6) 2008.

Manufacturer Narrative

Addendum to the initial report.Based on a review of additional medical records received.The patient underwent revision of a composix kugel hernia patch with implant of a bard/davol ventralight st using echo ps due to ongoing recurrent hernia.The patient's clinical course is not indicated beyond the revision procedure.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 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 a review of medical records and is an addendum to the previously provided information.(b)(6) 2015 - the patient underwent revision of bard/davol composix kugel hernia patch and implant of a bard/davol ventralight st using echo ps.

• Brand Name: MESH - COMPOSIX KUGEL
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; warwick RI
• 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: 4644095
• MDR Text Key: 5753371
• Report Number: 1213643-2015-00093
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 03/05/2015

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 Catalogue Number: 0010202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/05/2015
• Initial Date FDA Received: 03/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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