MAUDE Adverse Event Report: BARD SHANNON LIMITED AVAULTA PLUS MESH KIT; MESH,SURGICAL,NON-SYNTHETIC,UROGYNECOLOGIC,FOR PELVIC ORGAN PROLAPSE,TRANSVAGINA

Device Problem Material Erosion (1214)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994); Arthralgia (2355)

Event Date 11/08/2008

Event Type  Injury  

Event Description

Two bard avaulta plus mesh slings.Mesh erosion, chronic pain, inflammation, infection, joint pain.Removal scheduled (b)(6) 2020.Fda safety report id# (b)(4).

• Brand Name: AVAULTA PLUS MESH KIT
• Type of Device: MESH,SURGICAL,NON-SYNTHETIC,UROGYNECOLOGIC,FOR PELVIC ORGAN PROLAPSE,TRANSVAGINA
• Manufacturer (Section D): BARD SHANNON LIMITED
• MDR Report Key: 9677075
• MDR Text Key: 178197579
• Report Number: MW5092814
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/03/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 46 YR