MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. BARD FLAT MESH; SURGICAL MESH

Catalog Number 0112650

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

Patient Problems Unspecified Infection (1930); Pain (1994); Prolapse (2475); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown whether the device may have caused or contributed to the reported event.The patient's attorney did not allege a specific device failure or patient injury and medical records were limited to the patient's implant tracking log and implant op report only.A manufacturing review was performed and found no evidence of a manufacturing related cause for the alleged event.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.Not returned to manufacturer.

Event Description

The following is based on a review of limited medical records and the attorney's legal claim provided to davol by the patient's attorney: on (b)(6) 2006--patient was diagnosed with genital prolapse.The patient underwent a posterior intravaginal slingplasty, anterior/posterior repair with implant of a bard/davol flat mesh and a tension-free tape using a non bard/davol mesh.The attorney alleges the patient experienced and unspecified adverse outcome associated to the use of the device.

Manufacturer Narrative

This supplemental emdr is being sent to provide the original date of awareness in which was not previously provided as well as the correct expiration date for the bard flat mesh.

Manufacturer Narrative

Addendum to the previous information.The supplemental emdr is being sent due to patient allegations reported to davol by the patient's attorney.The legal claim provided alleges the patient experienced pain, infection, urinary problems, bowel problems, recurrence and bleeding.In regards to infection, the warning section in the instructions-for-use states "if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis.¿ limited medical records which included the patients implant op report, implant tracking log, 1 page of the patient's history and physical and 2 pages of anesthesia records were provided.With the current information available no definitive conclusion can be made.If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.

Event Description

The following is based on a review of limited medical records and the attorney's legal claim provided to davol by the patient's attorney: on (b)(6) 2006--patient was diagnosed with genital prolapse.The patient underwent a posterior intravaginal slingplasty with a non-bard davol ivs, anterior/posterior repair with implant of a bard/davol flat mesh and a tension-free tape using a non bard/davol mesh.The attorney's legal claim alleges the patient experienced pain, infection, urinary problems, bowel problems, recurrence and bleeding.

• Brand Name: BARD FLAT MESH
• 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: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 6171751
• MDR Text Key: 62314161
• Report Number: 1213643-2016-00571
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2010
• Device Catalogue Number: 0112650
• Device Lot Number: 43KPD137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2005
• 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): Other