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

Lot Number HUSK0108

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

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Incontinence (1928); Abnormal Vaginal Discharge (2123)

Event Date 01/01/2015

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 a patient had several mesh implants which resulted in mesh extrusion requiring surgery to remove.The patient experienced bleeding (vaginal), discharge (vaginal), urinary leaking, and additional surgery.The patient also had mesh erode into her rectum.She is on estrogen to keep the vaginal walls thick.

Manufacturer Narrative

The reported event could not be confirmed.No sample was returned for evaluation.A potential root cause of the reported event could be that the patient is not assessed for suitability and is not a good candidate for this surgery, either because physician does not know to check a patient for suitability, or physician does not know what makes a patient suitable for procedure.The dhr review was not required per the investigation summary.The product family for this unknown avaulta - bard product is unknown.Therefore, bard is unable to determine the associated labeling to review.Although the product family is unknown, the unknown avaulta - bard product ifus are found to be adequate based on past reviews.H11:section a through f - the information provided by bd 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 bd.The device was not returned.

Event Description

It was reported that a patient had several mesh implants which resulted in mesh extrusion requiring surgery to remove.The patient experienced bleeding (vaginal), discharge (vaginal), urinary leaking, and additional surgery.The patient also had mesh erode into her rectum.She is on estrogen to keep the vaginal walls thick.

• Brand Name: UNKNOWN AVAULTA - BARD
• Type of Device: UNKNOWN AVAULTA
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8579267
• MDR Text Key: 144097838
• Report Number: 1018233-2019-02320
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

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
• Device Lot Number: HUSK0108
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 05/03/2019
• Supplement Dates Manufacturer Received: 06/18/2019
• Supplement Dates FDA Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention