MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN AVAULTA - BARD; UNKNOWN AVAULTA SUPPORT SYSTEM

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

Patient Problems Erosion (1750); Failure of Implant (1924); 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 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 had an anterior vaginal mesh inserted 2009.In 2016, extrusion of the vaginal mesh was found, which required surgery that removed the mesh.

Event Description

It was reported that the patient had an anterior vaginal mesh inserted 2009.In 2016, extrusion of the vaginal mesh was found, which required surgery to remove the mesh.

Manufacturer Narrative

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

• Brand Name: UNKNOWN AVAULTA - BARD
• Type of Device: UNKNOWN AVAULTA SUPPORT SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7794544
• MDR Text Key: 117563308
• Report Number: 1018233-2018-03638
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K083840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2018
• Initial Date FDA Received: 08/17/2018
• Supplement Dates Manufacturer Received: 08/30/2018
• Supplement Dates FDA Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention