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

Model Number 0112720

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

Patient Problems Unspecified Infection (1930); Pain (1994); Urinary Frequency (2275)

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.The medical records provided included the patient's implant operative report, implant tracking log, a diagnostic lab results page and medical exam notes.A manufacturing review was performed which found no anomalies during the manufacturing process of the device.The information provided indicated that approximately 1 year post implant of the bard flat mesh, the patient was experienced possible bacterial vaginosis.At this time it is unknown to what extent if any the bard flat mesh may have contributed to the diagnosis of infection.In regards to infection, however, 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.¿ with the current information available, no definitive conclusion can be made as to the extent that the device may have caused or contributed to any post op complications.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' legal claim provided to davol by the patient's attorney: on (b)(6) 2009 - the patient was diagnosed with a vaginal prolapse and underwent a colposacropexy with implant of a bard flat mesh.Per operative details "attachment to the sacrum was attempted; however, the vagina was quite extended and there was no space between the vaginal cuff and the sacrum.Therefore, the mesh was sutured to the abdominal fascia." on (b)(6) 2010 - per a diagnostic lab result, the patient had a pap smear which indicated "shift in vaginal flora suggestive of bacterial vaginosis." on (b)(6) 2011 - the patient had an md office exam with complaints of vaginal dryness, discharge and occasional pain.Per the exam notes, the vaginal cuff and vagina were clean and no issues noted.The patient was prescribed vaginal hormonal cream to help relieve her vaginal dryness.On (b)(6) 2014 - the patient had an md office exam where the patient wanted to have her sugar checked due to complaints of dry skin, weight gain, blurred vision, extreme thirstiness, frequent urination and yeast infections.

• 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: 6819989
• MDR Text Key: 83623125
• Report Number: 1213643-2017-00523
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016561
• UDI-Public: (01)00801741016561(17)131028(10)HUSI2027
• 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
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2013
• Device Model Number: 0112720
• Device Catalogue Number: 0112720
• Device Lot Number: HUSI2027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2008
• 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): Required Intervention