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

Device Problems Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682)

Patient Problems Erosion (1750); Pain (1994); Discomfort (2330); Patient Problem/Medical Problem (2688)

Event Date 06/21/2018

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.

Event Description

It was reported that the patient allegedly experienced vaginal pain, excessive soreness, and erosion, due to implantation of the mesh on (b)(6) 2012 at the gynecologic department at (b)(6) hospital.During examination it was found that the implanted mesh migrated centrally and in the space between the vaginal wall and column.On (b)(6) 2018 a surgical procedure was performed to remove the two arms of the mesh that were in the left side of the vagina.

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 women's health mesh product ifus are found to be adequate based on past reviews.Patient code: (b)(6).

Event Description

It was reported that the patient experienced vaginal pain, excessive soreness and erosion, due to implantation of the mesh on (b)(6) 2012 at the gynecologic department at (b)(6) hospital.During examination it was found that the implanted mesh migrated centrally and in the space between the vaginal wall and column.On (b)(6) 2018 a surgical procedure was performed to removed the two arms of the mesh that were in the left side of the vagina.The patient status was unknown.

• Brand Name: AVAULTA PLUS
• Type of Device: AVAULTA PLUS MESH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7959989
• MDR Text Key: 123504197
• Report Number: 1018233-2018-04734
• 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: 11/30/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/12/2018
• Supplement Dates Manufacturer Received: 11/14/2018
• Supplement Dates FDA Received: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization