MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CONTIGEN® BARD® COLLAGEN IMPLANT

Catalog Number 651005

Device Problems Entrapment of Device (1212); Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Calcium Deposits/Calcification (1758); Micturition Urgency (1871); Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Liver Damage/Dysfunction (1954); Internal Organ Perforation (1987); Overdose (1988); Pain (1994); Scar Tissue (2060); Scarring (2061); Tissue Damage (2104); Urinary Tract Infection (2120); Stenosis (2263); Therapeutic Response, Decreased (2271); Urinary Frequency (2275); Reaction (2414); Obstruction/Occlusion (2422); Prolapse (2475); Ambulation Difficulties (2544); Blood Loss (2597); Dysuria (2684); Test Result (2695); Fibrosis (3167); No Code Available (3191)

Event Type  Injury  

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: urological applications: adverse events associated with treatment may include but are not limited to: worsened incontinence; urinary retention; urinary tract infection; and/or localized responses (including swelling, erythema, induration, infection, necrosis, abscess formation, and/or hypersensitivity response).Slight discomfort and mild bleeding will probably occur at the injection site immediately following the injection procedure.In the clinical evaluation, approximately 2% of treated patients reported pain at the injection site or injection site injury.Transient gross hematuria may occur immediately following the injection procedure.In the clinical evaluation of contigen implant, postprocedure hematuria occurred in approximately 2% of treated patients.The patient should be told to report increasing discomfort or swelling to the physician.(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

It was reported in the patient's medical records that as a result of having the product implanted, the patient has experienced pain, extrusion, unspecified urinary problems, organ perforation, recurrence, dyspareunia, vaginal scarring (scarring), erosion, infection, unspecified bowel problems, adhesions, urinary stress incontinence, internal sphincter deficiency, cystocele (prolapse), enterocele, chronic interstitial cystitis (inflammation), suprapubic/abdominal pain (abdominal pain), lumbago, urinary frequency, urinary urgency, dysuria, bladder calculus, foreign body in bladder (foreign body in patient), ulcerative colitis (ulceration), calcification, allergies, abnormal gait, overdose, partial small bladder obstruction (obstruction), inflammatory mass in colon, strictures, scar tissue, mixed portal inflammation, interlobular bile duct injury, periductal histiocytes, steatohepatitis/steatosis, perisinusoidal/portal/septal fibrosis (fibrosis), elevated liver function studies, acute and chronic serositis, lymph node reactive changes, cholelithiasis, adenomyosis of gallbladder wall, blood loss, and required additional surgical and non-surgical interventions.

• Brand Name: CONTIGEN® BARD® COLLAGEN IMPLANT
• Type of Device: CONTIGEN® BARD® COLLAGEN IMPLANT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd.; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON); 8195 industrial blvd.; covington GA 30014
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 5015997
• MDR Text Key: 23525397
• Report Number: 1018233-2015-00297
• 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
• Reporter Occupation: Attorney
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2009
• Device Catalogue Number: 651005
• Device Lot Number: CVQH0029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2006
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR