ALIGN URETHRAL SUPPORT SYSTEM BRD300RS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-24 for ALIGN URETHRAL SUPPORT SYSTEM BRD300RS manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[188328675] 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 adverse events: postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure. Urinary retention, bladder outlet obstruction and other voiding dysfunctions. These conditions may be associated with overcorrection/too much tension placed on the implant. Perforations or lacerations of vessels, nerves, bladder, bowel, urethra, or any viscera, which may occur during the implantation procedure. Irritation at the operative wound site which may elicit a foreign body response that leads to wound dehiscence, inflammation and/or infection. Extrusion through vaginal epithelium or erosion into surrounding viscera and/or mucosa. Inflammation, sensitization, pain, dyspareunia, scarification, contraction, device migration and failure of the procedure resulting in recurrence of incontinence. (b)(4). No sample received.
Patient Sequence No: 1, Text Type: N, H10


[188328676] It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced injury, pain, disability, impairment, stress urinary incontinence, additional non-surgical and surgical intervention, a palpable sling and sutures, sling mesh erosion, vaginal erosion of midurethral sling, midline cystocele, urgency of urination, uterine prolapse, recurrent sling exposure, atrophy, poor healing, mesh contracture, interstitial cystitis, pudendal neuralgia, dyspareunia, mesh rejection, pelvic pain, trigger point injections, and placement of rectus fascia autologous sling.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2020-02042
MDR Report Key9871192
Report SourceOTHER
Date Received2020-03-24
Date of Report2020-03-24
Date Mfgr Received2020-03-03
Device Manufacturer Date2012-08-07
Date Added to Maude2020-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactANGELA ROBINSON
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal30014
Manufacturer Phone7707846100
Manufacturer G1C.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal Code30014
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameALIGN URETHRAL SUPPORT SYSTEM
Generic NameALIGN URETHRAL SUPPORT SYSTEM
Product CodeOTN
Date Received2020-03-24
Model NumberBRD300RS
Catalog NumberBRD300RS
Lot NumberHUWG0724
Device Expiration Date2014-08-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age3 MO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerC.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Address8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-24

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