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

Catalog Number 651005

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

Patient Problems Erosion (1750); Unspecified Infection (1930); Liver Damage/Dysfunction (1954); Pain (1994); Discomfort (2330); Blood Loss (2597); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

It was reported in the pt's medical records that as a result of having the product implanted, the pt has experienced pain, bleeding, mesh erosion, dyspareunia, loss of consortium, vaginal scarring, bowel problems, infections and separation of the vaginal incision which necessitating excision on (b)(6) 2008, and removal on (b)(6) 2009.

Manufacturer Narrative

The sample was not returned.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials.(b)(4).

Manufacturer Narrative

(b)(4).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 foreign body in vagina (foreign body in patient), blood loss, palpation of vaginal band, mesh erosion (erosion), mesh rolled/shrunk at the ischial spine, dyspareunia, partial remnant, rectovaginal septum defects, fascial defect, right side rough area, bleeding, ¿feels like a suture or piece of mesh that is rubbing¿ (foreign body sensation), discomfort, kidney infections, atrophic mucosa, tight arch like adhesive band/restrictive (adhesions), tender, atrophic vulvovaginitis (inflammation), retained suture (foreign body in patient), and required nonsurgical and additional surgical interventions.

• Brand Name: CONTIGEN BARD COLLAGEN IMPLANT TREATMENT SYRINGES
• 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: 3565328
• MDR Text Key: 4076393
• Report Number: 1018233-2014-00002
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900030 S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2010
• Device Catalogue Number: 651005
• Device Lot Number: CVRH0008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2007
• 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
• Patient Age: 56 YR