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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 Injury (2348); Prolapse (2475); Intermenstrual Bleeding (2665)
Event Type  Injury  
Event Description

The patient's attorney alleged a deficiency against the device. Per additional information received, the patient has experienced pelvic organ prolapse, uterine prolapse, anterior compartment failure, vaginal hysterectomy with anterior compartment plasty, vaginal bleeding, bulge, stage i apical failure, pelvic pain, painful intercourse, genital hiatus 3 cm, multiple sclerosis, enterocele repair, iliococcygeus colpopexy, back pain, vaginal pain, spasms, increased frequency of urination, constipation, lesion. The patient additionally required surgical and non-surgical interventions.

 
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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 Key11056891
MDR Text Key223175898
Report Number1018233-2020-06388
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 12/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/13/2012
Device Catalogue Number482047
Device LOT Number09B08-8
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/22/2020
Distributor Facility Aware Date12/07/2020
Event Location Hospital
Date Report TO Manufacturer12/22/2020
Date Manufacturer Received12/07/2020
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: 12/22/2020 Patient Sequence Number: 1
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