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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; UNKNOWN MESH PRODUCT
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C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN BMD WOMEN'S HEALTH MESH PRODUCT; UNKNOWN MESH PRODUCT Back to Search Results
Device Problems Detachment Of Device Component (1104); Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Weakness (2145); Discomfort (2330); Depression (2361); Ambulation Difficulties (2544)
Event Date 01/13/2016
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.The device was not returned.
 
Event Description
It was reported that the patient allegedly experienced debilitating and often excruciating pain and discomfort.She states that her pain stems from where the mesh is attached to her sacrum and radiates across the buttocks, hips, legs, knees and feet.The patient alleges that she is unable to pick anything up because it is too heavy, restricted movement, and often inability to move which affects her daily activities.She also alleges difficulty with ambulation, lying in bed, and turning over in bed due to the agonizing pain.She states that the prolapse has returned, she is unable to have sex, and has suicidal feelings.The patient states that she was not informed of any complications other than the anterior prolapse possibly returning.The patient alleges that the mesh has detached from the sacrum and she is on the waiting list for the mesh removal.The device was implanted on 1018233-2018-02268 2016.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, a device history record could not be reviewed.Although the product family is unknown, the bard avaulta product ifus are found to be adequate based on past reviews.
 
Event Description
It was reported that the patient allegedly experienced debilitating and often excruciating pain and discomfort.She stated that her pain stemmed from where the mesh was attached to her sacrum and radiates across the buttocks, hips, legs, knees and feet.The patient alleged that she was unable to pick anything up because it was too heavy, restricted movement, and often inability to move which affects her daily activities.She also alleged difficulty with ambulation, lying in bed, and turning over in bed due to the agonizing pain.She stated that the prolapse has returned, she is unable to have sex, and has suicidal feelings.The patient stated that she was not informed of any complications other than the anterior prolapse possibly returning.The patient alleged that the mesh has detached from the sacrum and she was on the waiting list for the mesh removal.The device was implanted on (b)(6) 2016.
 
Event Description
It was reported that the patient allegedly experienced debilitating and often excruciating pain and discomfort.She stated that her pain stemmed from where the mesh was attached to her sacrum and radiates across the buttocks, hips, legs, knees and feet.The patient alleged that she was unable to pick anything up because it was too heavy, restricted movement, and often inability to move which affects her daily activities.She also alleged difficulty with ambulation, lying in bed, and turning over in bed due to the agonizing pain.She stated that the prolapse has returned, she is unable to have sex, and has suicidal feelings.The patient stated that she was not informed of any complications other than the anterior prolapse possibly returning.The patient alleged that the mesh has detached from the sacrum and she was on the waiting list for the mesh removal.The device was implanted on (b)(6)2016.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, a device history record could not be reviewed.Although the product family is unknown, the pelvic mesh product ifus are found to be adequate based on past reviews.Additional patient codes:(b)(4).Correction: concomitant medical products.
 
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Brand Name
UNKNOWN BMD WOMEN'S HEALTH MESH PRODUCT
Type of Device
UNKNOWN MESH PRODUCT
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key7607889
MDR Text Key111338232
Report Number1018233-2018-02278
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
PMA/PMN Number
K093747
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup
Report Date 06/28/2018
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? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/23/2018
Initial Date FDA Received06/15/2018
Supplement Dates Manufacturer Received06/19/2018
06/27/2018
Supplement Dates FDA Received06/21/2018
06/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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