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U.S. Department of Health and Human Services

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

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C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN BMD WOMEN¿S HEALTH MESH PRODUCT Back to Search Results
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.
 
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Brand NameUNKNOWN BMD WOMEN¿S HEALTH MESH PRODUCT
Type of DeviceUNKNOWN 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 Key12915266
MDR Text Key281583072
Report Number1018233-2021-80103
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received12/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received11/15/2021
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
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