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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ALIGN® S URETHRAL SUPPORT SYSTEM SUPRAPUBIC

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C.R. BARD, INC. (COVINGTON) -1018233 ALIGN® S URETHRAL SUPPORT SYSTEM SUPRAPUBIC Back to Search Results
Model Number BRD200S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Erosion (1750); Calcium Deposits/Calcification (1758); Cyst(s) (1800); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Injury (2348); Disability (2371); Prolapse (2475); Dysuria (2684); Fluid Discharge (2686); Dyspareunia (4505); Urinary Incontinence (4572)
Event Type  Injury  
Manufacturer Narrative
Adverse events: complications associated with the proper implantation of the align® urethral support system may include, but are not limited to: "postoperative hematoma, which may occur following the implant procedure, temporary urinary retention, bladder outlet obstruction, voiding difficulties associated with over-correction/too much tension placed on the mesh sling implant, perforations or lacerations of vessels, nerves, bladder or any viscera, which may occur during introducer needle passage, transitory irritation at the operative wound site, which may elicit a foreign body response that leads to inflammation, infection and erosion of the implant." (b)(4).Report is late due to the fda ¿exemption of (b)(6) transition period.(b)(4) june 27, 2019 sample not received.
 
Event Description
The patient¿s attorney alleged a deficiency against the device.Per additional litigation received, the patient has experienced pain, injury, disability and impairment.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Per additional information received on 04jun2021, the patient experienced severe pain, dyspareunia, inability to walk normally, mesh erosion, bleeding, recurrent incontinence, urethral mesh exposure, stress urinary incontinence, ovarian cyst, pelvic trauma, recurrent vaginal or bladder infections, recurrent vaginal pain, urethral diverticulum, unspecified urethral stricture, lesion, cystitis, urinary frequency, mixed urinary incontinence, urine leakage, urge incontinence, urethral reconstruction, chronic overactive bladder syndrome, calculus of kidney, urinary tract infection, hydronephrosis, chronic dysuria, severe urethral hypermobility, first degree cystocele, abdominal pain, prolapse and required additional surgical and non-surgical interventions.
 
Event Description
Per additional information received via medical records on 21apr2023, the patient has experienced urethral stricture, eroded mesh in the urethra, urethral diverticulum, stress urinary incontinence, urethral mesh exposure and required additional non-surgical treatments.
 
Manufacturer Narrative
2371, 1685, 1799, 1871, 2686, 1758, 2120, 2684, 2475 =nl.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
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Brand Name
ALIGN® S URETHRAL SUPPORT SYSTEM SUPRAPUBIC
Type of Device
ALIGN® S URETHRAL SUPPORT SYSTEM SUPRAPUBIC
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
xeeroy rada
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key8742206
MDR Text Key149689497
Report Number1018233-2019-03430
Device Sequence Number1
Product Code OTN
UDI-Device Identifier00801741016189
UDI-Public(01)00801741016189
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093747
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 05/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2009
Device Model NumberBRD200S
Device Catalogue NumberBRD200S
Device Lot NumberHUSG1219
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Device Age2 MO
Event Location Hospital
Initial Date Manufacturer Received 05/28/2019
Initial Date FDA Received06/27/2019
Supplement Dates Manufacturer Received06/04/2021
04/21/2023
Supplement Dates FDA Received06/08/2021
05/15/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/22/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age43 YR
Patient SexFemale
Patient Weight64 KG
Patient EthnicityHispanic
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