MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PELVILACE® TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HOOK NEEDLE

Catalog Number 482151

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

Patient Problems Incontinence (1928); Injury (2348); Hematuria (2558)

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: ¿potential complications associated with the proper implantation of the pelvilace¿ to system may include, but are not limited to: postoperative hematoma, which may occur following the implant procedure.Temporary urinary retention, bladder outlet obstruction, and voiding difficulties associated with over-correction/too much tension placed on the implant.Perforations or lacerations of vessels, nerves, bladder or bowel, which may occur during needle passage.Transitory irritation at the operative wound site, which may elicit a foreign body response that leads to inflammation, infection, or erosion at the implant site." (b)(4).

Event Description

The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced hematuria, urinary incontinence, use of protective pads daily, vaginal bleeding, constipation, straining with bowel movements, frequency due to high fluid intake, nocturia, small erosion, cystocele, spotting, vaginal itching, tightening sensation in her buttocks, atrophic vaginitis, recurrence of erosion and required multiple surgical and nonsurgical interventions.

• Brand Name: PELVILACE® TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HOOK NEEDLE
• Type of Device: PELVILACE® TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HOOK NEEDLE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 8948156
• MDR Text Key: 156114467
• Report Number: 1018233-2019-05229
• Device Sequence Number: 1
• Product Code: PAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/29/2019

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: 01/31/2012
• Device Catalogue Number: 482151
• Device Lot Number: CVTH0006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 1 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2009
• 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: 67 YR
• Patient Weight: 64