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 Problems Pain (1994); Hernia (2240); Disability (2371)

Event Date 06/23/2010

Event Type  Injury  

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. 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.

• 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
• MDR Report Key: 7142549
• MDR Text Key: 291323464
• Report Number: 1213643-2017-01098
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K002684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/28/2011
• Device Model Number: 0123810
• Device Catalogue Number: 0123810
• Device Lot Number: 43AQD352
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 12/22/2017 Patient Sequence Number: 1