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

Catalog Number 651005

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

Patient Problems Micturition Urgency (1871); Unspecified Infection (1930); Internal Organ Perforation (1987)

Event Type  Injury  

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.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)(6).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 one revision of the vaginal mesh when an arm of the anterior vaginal graft mesh was cut for dyspareunia and pelvic pain; one attempted lysis of the sling and mesh arm; however, no clear mesh banding was found during the surgery so scar tissue was lysed; one surgical revision of the sling when an additional sling was implanted for recurrent stress urinary incontinence and intrinsic sphincter deficiency and one excision of tot sling for irritative voiding, pain, and partial urinary retention.The patient also underwent one transabdominal excision of pelvic mesh for extrusion into the urinary bladder and chronic pain from scarring related to the mesh; developed a post-operative infection of the abdominal incision post-mesh removal which required one in-office aspiration, one hospitalization for infection and cellulitis of the abdominal wound, one in-office silver nitrate treatment, three surgical excisions of granulation tissue and wound debridement.In addition, she underwent five cystoscopies with injections of periurethral collagen for intrinsic sphincter deficiency and recurrent stress urinary incontinence; four in-office injections of steroid and local anesthetic to the pelvic floor for pelvic pain and dyspareunia and three procedures related to generator and lead placements associated with neurostimulation devices implanted for treatment of overactive bladder, urge incontinence, and frequency.The patient also was treated with one in-office injection of steroid and local anesthetic for right sacroiliitis with increasing pain associated with a urinary tract infection; three in-office trigger point injections with steroid and local anesthetic for pelvic pain and urinary retention with temporary response followed by an in-office trigger point injection with botox and local anesthetic with the goal of providing a more sustained relief of her urinary retention and pelvic pain; two surgical transurethral incisions of the bladder/vesicle neck for urinary retention with bladder neck obstruction after botox injection failed to help the urinary retention; and one er visit for replacement of the foley catheter after the catheter fell out following one of the transurethral incision procedures.She also suffered from urinary retention requiring self-catheterization, pelvic floor muscle spasms and myofascial restriction in the pelvic area requiring pelvic floor therapy, pelvic floor weakness, chronic klebsiella urinary tract infections, recalcitrant/recurrent urinary tract infections requiring picc line placement for antibiotic therapy, abdominal/ bilateral flank/groin/back/urethral/pelvic pain, severe stress urinary incontinence, vaginal and rectal bleeding, dyspareunia, grade three cystocele with recurrent hypermobility, small anal fissure, hematochezia, vaginal pressure, mild to moderate rectocele, abnormal functional bladder capacity, detrusor instability with urinary frequency and nocturia, vaginal atrophy, buttock and tailbone pain from interstim, urethrocele, vaginal cuff scarring, vaginal discharge, chronic interstitial cystitis, constipation and bladder instability, treatment of a yeast infection, intolerance of treatment with anticholinergics due to significant dry mouth.She was also diagnosed with diabetes mellitus and fibromyalgia.

• 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: lisa hall ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5341856
• MDR Text Key: 34980435
• Report Number: 1018233-2016-00003
• 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
• Type of Report: Initial
• Report Date: 12/10/2015

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 Catalogue Number: 651005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/10/2015
• Initial Date FDA Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: CONTIGEN BARD COLLAGEN IMPLANT
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 71