MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN BMD WOMEN¿S HEALTH MESH PRODUCT

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Micturition Urgency (1871); Incontinence (1928)

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed. The product family and lot number are unknown. No sample was returned for investigation. No review or conclusions could be made regarding the alleged deficiencies. The product family for this women¿s healthcare product is unknown, and no sample was returned for investigation. No review or conclusions could be made regarding the alleged deficiencies. The product family for this women¿s healthcare product is unknown. Therefore, bard is unable to determine the associated labeling to review. Although the product family is unknown, the women¿s health product ifus are found to be adequate based on past reviews.

Event Description

The patient¿s attorney has alleged a deficiency against the device. The litigation does not specifically state which product was used on the patient therefore an unknown complaint is being entered. Additional information has been requested but not yet received. Per additional information received on 15nov2021, the patient has experienced mesh extrusion protruded through the vaginal mucosa, mixed incontinence, urinary urgency, amenorrhea, and required additional surgical and non-surgical interventions.

• Brand Name: UNKNOWN BMD WOMEN¿S HEALTH MESH PRODUCT
• Type of Device: UNKNOWN BMD WOMEN¿S HEALTH MESH PRODUCT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 12915266
• MDR Text Key: 281583072
• Report Number: 1018233-2021-80103
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/02/2021 Patient Sequence Number: 1