MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) CONTIGEN BARD COLLAGEN IMPLANT

Catalog Number 651005

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Pain (1994); Scar Tissue (2060); Injury (2348)

Event Type  Injury  

Event Description

The patient's attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.

Manufacturer Narrative

The sample was not returned.The finished product met all specifications prior to being released for general distribution.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials.The instructions for use states in the adverse events: (b)(4).

Manufacturer Narrative

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.

Event Description

Per additional information received, the patient has experienced vaginal apex mesh erosion, pain, unspecified urinary problems, unspecified bowel problems, recurrence, vaginal scarring and required additional surgical interventions.

• Brand Name: CONTIGEN BARD COLLAGEN IMPLANT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON); covington GA
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON); 8195 industrial blvd.; covington GA 30014
• Manufacturer Contact: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 4514786
• MDR Text Key: 18545987
• Report Number: 1018233-2015-00037
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Attorney
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2009
• Device Catalogue Number: 651005
• Device Lot Number: CVQK0010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 5 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/15/2015
• Initial Date FDA Received: 02/11/2015
• Supplement Dates Manufacturer Received: 09/28/2017
• Supplement Dates FDA Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2006
• 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
• Treatment: URETEX TO2 URETHRAL SUPPORT SYSTEM W/HOOK NEEDLE; CONTIGEN BARD COLLAGEN IMPLANT; PELVITEX POLYPROPYLENE MESH
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR