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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 482812
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Injury (2348); Prolapse (2475)
Event Type  Injury  
Event Description
The patient's attorney alleged a deficiency against the device. Per additional information received, the patient has experienced a postoperative drop in hematocrit with shortness of breath requiring two units of blood, recurrent cystocele with pain, severe bladder neck hypermobility, rectocele, stress incontinence, poor emptying, and chronic urinary tract infections. She has required 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 Key8922452
MDR Text Key155342507
Report Number1018233-2019-05004
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 08/22/2019,01/05/2021
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 Number482812
Device Lot Number04B20-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/22/2019
Distributor Facility Aware Date12/11/2020
Event Location Hospital
Date Report to Manufacturer08/22/2019
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: 08/22/2019 Patient Sequence Number: 1
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