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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 Erosion (1750); Chest Pain (1776); Hemorrhage/Bleeding (1888); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Prolapse (2475); Dyspareunia (4505); Urinary Incontinence (4572)
Event Type  Injury  
Event Description
This complaint is being opened in association with the alleged event filed by the patient¿s attorney in complaint number(s) (b)(4). There have been no allegations of deficiency or serious injury against this device. This device is listed in the patient¿s medical record. Per additional information received via medical records on 20jul2021, the patient experienced severe pain, vaginal bleeding, painful sexual intercourse, mesh erosion, cystocele, recurrent vaginal yeast infections, recurrent vaginal pain, urinary incontinence, urinary retention, uterine prolapse, vaginal vault prolapse, dyspareunia, vaginal graft exposure, urinary frequency, urinary tract infection, breast pain and required additional 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
Manufacturer (Section G)
TISSUE SCIENCE LABORATORIES
astley lane industrial estate
unit 1
swillington, leeds LS26 8XT
UK LS26 8XT
MDR Report Key12272080
MDR Text Key264950447
Report Number1018233-2021-80057
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
Type of Report Initial
Report Date 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/03/2014
Device Catalogue Number482812
Device Lot Number10B159
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received07/20/2021
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: 08/03/2021 Patient Sequence Number: 1
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