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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PELVICOL ACELLULAR COLLAGEN MATRIX PELVICOL® ACELLULAR COLLAGEN MATRIX

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C.R. BARD, INC. (COVINGTON) -1018233 PELVICOL ACELLULAR COLLAGEN MATRIX PELVICOL® ACELLULAR COLLAGEN MATRIX Back to Search Results
Catalog Number 482047
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Incontinence (1928); Injury (2348); Foreign Body In Patient (2687)
Event Type  Injury  
Event Description
The patient¿s attorney alleged a deficiency against the device. Per additional information received via medical records the patient has experienced foreign body in patient, pelvic pain, urgency, frequency, erosion, recurrence, extrusion, infection, unspecified urinary problems, vaginal scarring (scar tissue), positive urine culture, nocturia, pyuria, abnormal urinary stream, fecal and flatus incontinence, recurrent stress incontinence, urgency of urination, urinary frequency, midline cystocele, urge incontinence, pressure, non-surgical interventions and one surgical intervention.
 
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Brand NamePELVICOL ACELLULAR COLLAGEN MATRIX
Type of DevicePELVICOL® ACELLULAR COLLAGEN MATRIX
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9208966
MDR Text Key165475725
Report Number1018233-2019-06599
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 10/18/2019,01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/17/2010
Device Catalogue Number482047
Device Lot Number07B05-9
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/18/2019
Distributor Facility Aware Date12/11/2020
Event Location Hospital
Date Report to Manufacturer10/18/2019
Date Manufacturer Received12/11/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/18/2019 Patient Sequence Number: 1
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