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

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); Tissue Breakdown (2681)

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 experienced vaginal erosion of the mesh which required excision.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown therefore the device history record could not be reviewed.The product family for this unknown avaulta - bard product is unknown.Therefore, the associated labeling cannot be determined for 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.H3 other text : the device was not returned.

Event Description

It was reported that the patient experienced vaginal erosion of the mesh which required excision.

• 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: 8896363
• MDR Text Key: 154402435
• Report Number: 1018233-2019-04734
• 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: 08/23/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 08/20/2019
• Supplement Dates FDA Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention