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U.S. Department of Health and Human Services

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

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C.R. BARD, INC. (COVINGTON) -1018233 PELVISOFT ACELLULAR COLLAGEN BIOMESH PELVISOFT® ACELLULAR COLLAGEN BIOMESH Back to Search Results
Catalog Number 481812
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abscess (1690); Arthritis (1723); Calcium Deposits/Calcification (1758); Chest Pain (1776); Diarrhea (1811); Fatigue (1849); Fever (1858); Headache (1880); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Pain (1994); Sepsis (2067); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Blurred Vision (2137); Urinary Frequency (2275); Discomfort (2330); Depression (2361); Prolapse (2475); Abdominal Cramps (2543); Intermenstrual Bleeding (2665); Dysuria (2684); Total Hearing Loss (4473); Renal Impairment (4499)
Event Type  Injury  
Manufacturer Narrative
The reported event could not be confirmed. No sample was returned for evaluation. Based on the investigation findings, current manufacturing controls are considered adequate as to detect and segregate any non-conforming unit. Event described could not be confirmed as a manufacturing related issue. The alleged event is most likely associated with possible procedural/surgical complications. The ifu currently addresses potential risks associated with surgically implantable materials which states the following: precautions: pelvisofttm biomesh is for single-patient use only and is to be implanted surgically. If either the outer polyester/polyethylene pouch or the inner foil pouch has been perforated or torn in shipment or storage, then the enclosed pelvisofttm biomesh should not be used. Pelvisofttm biomesh should be hydrated or moist when the package is opened. Dehydrated or dry tissue should not be implanted. Contraindications: use of the pelvisofttm biomesh is contraindicated for patients experiencing any of the following conditions: pregnancy, urinary tract infection, anticoagulant therapy, and/or infection in the operative field. (b)(4).
 
Event Description
It was reported by the patient's attorney that as a result of having the products implanted the patient has suffered serious bodily injuries, including extreme pain, infection of her bodily tissue, dyspareunia, significant mental and physical pain and suffering, undergone multiple surgeries and revisionary procedures and has sustained permanent injury. Product was used for therapeutic treatment. Per additional information received, the patient has experienced postoperative fevers and rigors, pelvic pain, pelvic abscess, urinary incontinence, bladder suspension, detrusor instability, grade 3 rectocele, grade 3 enterocele, recurrent urinary tract infections and dyspareunia per additonal information received, the patient has experienced fever, sepis, kidney stopped working for 12 hours, hospitalization on 12/25/2007 through 12/31/2007, erosion of mesh, bleeding, pain, and continuing pain during intercourse. Per additional information received on 11oct2021, the patient has experienced bleeding and erosion through vaginal wall, fever, sepsis, renal impairment, chronic and severe pain, pain during sexual intercourse, bladder infections, prolapse, chest pain, cystocele, hypertension, depression, stress urinary incontinence, blurred vision, lower abdominal pain, urinary frequency, nocturia, urge incontinence, pain in right breast, loss of hearing unspecified, esophageal reflux, meniere¿ disease unspecified, urinary calculi, osteoarthrosis, fibromyalgia, migraine headache, unspecified hyperlipidemia, rectocele, fatigue, urinary tract infection site not specified, seasonal allergies, pelvic pain, arthritis, bladder suspension, pelvic abscess, osteoporosis, cough, nephrolithiasis, dysuria, diarrhea, abdominal cramps, vaginal discharge, coronary artery disease, hypercholesterolemia, palpitations, vulvar atrophy, overactive bladder syndrome, acute right lumbar radiculopathy, spinal stenosis of lumbosacral region, sacroiliac joint dysfunction of right side, degenerative disc disease, insomnia, tinnitus, sinusitis, discomfort, green discharge and required additional surgical and non-surgical interventions.
 
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Brand NamePELVISOFT ACELLULAR COLLAGEN BIOMESH
Type of DevicePELVISOFT® ACELLULAR COLLAGEN BIOMESH
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key12721477
MDR Text Key279315441
Report Number1018233-2021-80087
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031332
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 10/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2012
Device Catalogue Number481812
Device Lot Number09B10-8
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Device Age10 MO
Event Location Hospital
Date Manufacturer Received10/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/29/2021 Patient Sequence Number: 1
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