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

Model Number BRD400HK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Erosion (1750); Fatigue (1849); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Injury (2348); Disability (2371); Prolapse (2475); Dyspareunia (4505); Urinary Incontinence (4572)

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 adverse events: ¿complications associated with the proper implantation of the align¿ to 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, and 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, or erosion of the implant." (b)(4).

Event Description

It was reported by the patient's attorney that as a result of having the product implanted the patient has experienced pain, injury, disability, and impairment.

Manufacturer Narrative

Correction: mdr date of awareness.

Manufacturer Narrative

1750, 2120, 2475 = "l".2560, 1760, 1908 = "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.

Event Description

Per additional information received via medical records on 30mar2022, the patient has experienced mesh erosion, chronic pain, vaginal bleeding, urinary tract infections, lethargic, anemia, diverticulitis, dyspareunia, hypertension, uterine prolapse and required additional surgical and non-surgical interventions.

Event Description

As per additional information received via medical records on 08jan2024, the patient had experienced mesh erosion, chronic pain, vaginal bleeding, atrophic vaginitis, urinary tract infection, lethargic, urinary incontinence, anemia, uterine prolapse, cystocele, diverticulitis, dyspareunia, hypertension, recurrent or chronic vaginal or bladder infections, lower back pain, malaise and fatigue and required additional surgical non-surgical treatment.

Manufacturer Narrative

1932, = "l".1994,2348,2371,1706,1888,1928,1849= "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.

• Brand Name: ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK
• Type of Device: ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK
• 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 Key: 10513802
• MDR Text Key: 206318193
• Report Number: 1018233-2020-05792
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 00801741016219
• UDI-Public: (01)00801741016219
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/31/2024

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 Date: 11/01/2009
• Device Model Number: BRD400HK
• Device Catalogue Number: BRD400HK
• Device Lot Number: CVRK0017
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 18 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 08/28/2020; 03/30/2022; 01/08/2024
• Supplement Dates FDA Received: 09/24/2020; 04/19/2022; 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AVAULTA PLUS® BIOSYNTHETIC SUPPORT SYSTEM; AVAULTA PLUS® BIOSYNTHETIC SUPPORT SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Race: White