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U.S. Department of Health and Human Services

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

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C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN BMD WOMENS HEALTH MESH PRODUCT UNKNOWN BMD WOMEN¿S HEALTH MESH PRODUCT Back to Search Results
Catalog Number Z48?
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Incontinence (1928); Injury (2348); Prolapse (2475)
Event Type  Injury  
Manufacturer Narrative
The sample was not returned. The lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials. The instructions for use states in the adverse events: ¿the product family for this women¿s healthcare product is unknown. Therefore, bard is unable to determine the associated labeling and dfmea to review. Although the product family is unknown, the women¿s health product ifus are found to be adequate based on past reviews. " (b)(4).
 
Event Description
It was reported in the patient¿s medical records that as a result of having the product implanted, the patient has experienced abdominal adhesive disease, abdominal foreign body (previous gore-tex sacrocolpopexy), recurrent cervical stump prolapse, cystocele, rectocele, enterocele, urethrovesical junction hypermobility, stress urinary incontinence and required one surgical intervention.
 
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Brand NameUNKNOWN BMD WOMENS 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
angela robinson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key8921760
MDR Text Key155266625
Report Number1018233-2019-04987
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberZ48?
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received08/16/2019
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: 08/22/2019 Patient Sequence Number: 1
Treatment
GORTEX MYCROMESH
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