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

Catalog Number UNKAA015

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 e/x (device #1). The attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided. The cause of the patient postoperative complications cannot be determined at this time. 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 at this time. Should additional information be provided a supplemental emdr will be submitted. This emdr represents the bard/davol composix e/x (device #1). There is no allegation related to the bard/davol phasix and phasix st. Not returned.

Event Description

Attorney alleges that the patient underwent surgery for implant of an unspecified bard/ davol composix e/x (device #1), an unspecified bard/davol phasix and an unspecified bard/ davol phasix st on (b)(6) 2010. It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s). As reported, the patient is making a claim for an adverse patient outcome against the bard/davol composix e/x (device #1). As reported, the attorney alleges patient experienced emotional distress, the device was defective and wrongful death.

• Brand Name: COMPOSIX E/X
• 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: jan ling ; 100 crossings blvd.; warwick, RI 02886 ; 8015652300
• MDR Report Key: 9466895
• MDR Text Key: 170688800
• Report Number: 1213643-2019-12124
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes

Device Operator

• Device Catalogue Number: UNKAA015
• 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: 12/02/2019
• 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: 12/13/2019 Patient Sequence Number: 1