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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

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C.R. BARD, INC. (COVINGTON) -1018233 PELVISOFT® ACELLULAR COLLAGEN BIOMESH Back to Search Results
Catalog Number 481812
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Micturition Urgency (1871); Urinary Frequency (2275); Injury (2348)
Event Type  Injury  
Manufacturer Narrative
The sample was not returned. The finished product met all specifications prior to being released for general distribution. The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials. The instructions for use states in the 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. " (b)(4).
 
Event Description
The patient's attorney alleged a deficiency against the device. Per additional information received, the patient has experienced urinary frequency, urinary urgency, recurrent vaginal vault prolapse, ongoing vaginal discomfort and fullness due to prolapse, suprapubic pain especially when walking a lot or lifting, leakage of urine with valsalva maneuvers, incomplete emptying of bladder, urinary tract infections, dyspareunia, grade two to three enterocele, grade one to two rectocele, very thin vaginal mucosa where the mesh is palpable, groin and suprapubic pain, pelvic pain, recurrent pelvic organ prolapse, mixed stress (recurrent) and urge urinary incontinence, severe scarring, possible contracture of mesh and mesh deep beneath vaginal mucosa close to the bladder and ureters, previous mesh and scarring, urinary retention and required nonsurgical interventions and one surgical intervention.
 
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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
angela robinson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key9144753
MDR Text Key162316187
Report Number1018233-2019-06138
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 Non-Healthcare Professional
Type of Report Initial
Report Date 10/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2012
Device Catalogue Number481812
Device Lot Number09B07-1
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 Received09/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/29/2009
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: 10/02/2019 Patient Sequence Number: 1
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