MAUDE Adverse Event Report: C. R. BARD, INC. AVAULTA ; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC FOR PELVIC ORGAN PROLAPSE, TRANSVAGINA

Lot Number HUTA1632

Device Problems Material Erosion (1214); Material Protrusion/Extrusion (2979)

Patient Problems Hemorrhage/Bleeding (1888); Incontinence (1928); Abnormal Vaginal Discharge (2123)

Event Date 01/01/2015

Event Type  Injury  

Event Description

Mesh was implanted in (b)(6) 2009 for pop.Vaginal bleeding began around 5/6 years later.Finally went to dr who did not do surgery, and he found mesh exposed in vagina in 2016, which he removed and then again in 2018, removing more mesh (both done in his office).In (b)(6) 2018, i went to urologist due to urinary leakage that has been happening for years.She found mesh exposed in vagina by rectum which required outpatient surgery.Although on estrogen to keep vaginal walls thick, mesh has been eroding into vagina requiring removal by drs.Urinary leakage and vaginal discharge ongoing.

• Brand Name: AVAULTA
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC FOR PELVIC ORGAN PROLAPSE, TRANSVAGINA
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 8473681
• MDR Text Key: 140729027
• Report Number: MW5085487
• 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: 03/25/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: HUTA1632
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 72