MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. SEPRAMESH IP SURGICAL MESH

Catalog Number 5959812

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

Patient Problems Fatigue (1849); Pain (1994); Injury (2348)

Event Date 03/15/2017

Event Type  Injury  

Manufacturer Narrative

Based on the limited information provided in the legal claim we are unable to determine to what extent, if any, the sepramesh ip may have caused or contributed to the events as alleged. Additional information has been requested. The surgery dates are estimates as the exact dates for the procedures were not provided. Should additional information be obtained, a supplemental emdr will be submitted. Note: the legal claim was not immediately forwarded to field assurance for processing. As such this report is being filed beyond the initial 30-day notification period. Note: 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

The following was alleged by the patient's attorney. In (b)(6) 2011 the patient was implanted with a davol sepramesh ip. As alleged the mesh failed and in october, 2013 the patient underwent surgery to remove part of the sepramesh ip. As reported in (b)(6) 2017 the patient underwent an additional procedure to remove the remainder of the sepramesh ip. It is alleged that during both of the subsequent surgeries the patient was implanted with unspecified mesh. The patient's attorney alleges that the patient suffered chronic pain and fatigue / lethargy and general injuries to her abdomen as a result of the defective mesh. It is alleged that the patient's symptoms of chronic pain and fatigue / lethargy have continued throughout and following the surgery in (b)(6) 2017.

• Brand Name: SEPRAMESH IP
• 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: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 7568911
• MDR Text Key: 110067913
• Report Number: 1213643-2018-01806
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K063739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/28/2013
• Device Catalogue Number: 5959812
• Device Lot Number: HUVF0220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/05/2018 Patient Sequence Number: 1