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

Catalog Number 482152

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

Patient Problems Injury (2348); Deformity/ Disfigurement (2360); Disability (2371)

Event Type  Injury  

Manufacturer Narrative

Sample not received.

Event Description

It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced injury, pain, disability, disfigurement and impairment.Product was used for therapeutic treatment.Per additional information received, the patient has experienced mesh erosion, recurrent infection, granulation tissue reaction with edema, and acute inflammation.The patient additionally required surgical and non-surgical interventions.

• Brand Name: PELVILACE TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HALO NEEDLE
• Type of Device: PELVILACE® TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HALO 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: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 11004499
• MDR Text Key: 221465456
• Report Number: 1018233-2020-06378
• 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: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2010
• Device Catalogue Number: 482152
• Device Lot Number: CVRE0003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2007
• 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
• Treatment: AVAULTA SOLO® SYNTHETIC SUPPORT SYSTEM - ANTERIOR
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR