MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 AVAULTA SOLO

Catalog Number UNKNOWN

Device Problems Patient-Device Incompatibility (2682); Material Protrusion/Extrusion (2979)

Patient Problems Erosion (1750); Discomfort (2330); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the patient started experiencing issues with vaginal mesh extrusion in 2016.The patient sought medical attention from a surgeon in 2016 and 2017 who performed "conservative treatment".The patient then sought medical attention from another doctor who plans to remove part of the mesh and close over the vagina.Per additional information received from the ibc on 11-oct-2018, the patient did not suffer blood loss.She received vaginal estrogen treatment.The patient also noted that she and her partner feel the mesh during intercourse which was uncomfortable.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the avaulta solo product ifus are found to be adequate based on past reviews.Correction: event.

Event Description

It was reported that the patient started experiencing issues with vaginal mesh extrusion in 2016.The patient sought medical attention from a surgeon in 2016 and 2017 who performed "conservative treatment".The patient then sought medical attention from another doctor who removed part of the mesh and close over the vagina.Additional information was received from the ibc on (b)(6)2018, that the patient did not suffer blood loss.She received vaginal estrogen treatment.The patient also noted that she and her partner feel the mesh during intercourse which was uncomfortable.

• Brand Name: AVAULTA SOLO
• Type of Device: AVAULTA SOLO
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8001883
• MDR Text Key: 124957332
• Report Number: 1018233-2018-04951
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K083839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/03/2018
• Initial Date FDA Received: 10/24/2018
• Supplement Dates Manufacturer Received: 12/23/2018
• Supplement Dates FDA Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention