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

Catalog Number UNKAA016

Device Problems Defective Device (2588); Insufficient Information (3190)

Patient Problems Death (1802); Injury (2348)

Event Type  Death  

Manufacturer Narrative

At this time no conclusions can be made regarding the bard/davol composix kugel (device #1) used to treat the patient. The patient's attorney did allege surgical intervention and death; however, no details have been provided. No medical records, autopsy, or death certificate have been provided. No lot number has been provided therefore a review of the manufacturing records is not possible. Should additional information be provided a supplemental emdr will be submitted. This emdr represents the bard/davol composix kugel (device #1). An additional emdr was submitted to represent the bard/davol sepramesh ip (device #2). Not returned.

Event Description

Attorney alleges that on (b)(6) 2005 or (b)(6) 2010, the patient underwent surgery for implant of an unspecified bard/davl composix kugel hernia patch (device #1) or an unspecified bard/davol sepramesh ip (device #2). It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device. As reported, the patient is making a claim for an adverse patient outcome against the composix kugel hernia patch (device #1) and the sepramesh ip (device #2). As reported, the attorney alleges wrongful death, the product is defective, and that the patient experienced emotional distress.

• Brand Name: 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: roxanne tidwell ; 100 crossings blvd.; warwick, RI 02886 ; 8015652300
• MDR Report Key: 8605670
• MDR Text Key: 144885167
• Report Number: 1213643-2019-03804
• 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: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: Yes

Device Operator

• Device Catalogue Number: UNKAA016
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/23/2019
• 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 Treatment Data

Date Received: 05/13/2019 Patient Sequence Number: 1