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 Abdominal Pain (1685); Abscess (1690); Erosion (1750); Diarrhea (1811); Emotional Changes (1831); Fistula (1862); Micturition Urgency (1871); Headache (1880); Pyrosis/Heartburn (1883); Incontinence (1928); Nerve Damage (1979); Pain (1994); Sepsis (2067); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Pressure Sores (2326); Anxiety (2328); Discomfort (2330); Injury (2348); Arthralgia (2355); Disability (2371); Fasciitis (2375); Numbness (2415); Neck Pain (2433); Hematuria (2558); Intermenstrual Bleeding (2665); Constipation (3274); Stomach Ulceration (4488); Dyspareunia (4505); Rectovaginal Fistula (4509)

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

1750, 2120="l".2665, 2330, 2328="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 on 24nov2021, the patient has experienced vaginal problem, bleeding after intercourse, discomfort, sometimes spotting, mesh erosion, headache, chronic pain syndrome, anxiety, eczema, postcoital bleeding, menorrhagia, failed hydrothermal ablation, vaginal infections, left leg and poss rectal pain, brown discharge, rectal or buttock abscess, necrotizing fasciitis, vaginal-rectal fistula, chronic pain of left knee, dyspareunia, nocturia, post-menopausal bleeding, urinary urgency, urge incontinence, hispareunia, left upper extremity numbness, chronic neck pain, recurrent carpal tunnel syndrome, polyarthropathy, heart burn, soreness of the fingers, joint pain, polyarthralgia¿s, gastroesophageal reflux disease, galactorrhea, chronic back pain, chronic myofascial back pain, hematuria, right sided pelvic pain, right lower quadrant abdominal pain, palpitations, appendicitis, heavy bleeding, urinary frequency, urinary tract infection, kidney stones, constipation, uncontrolled uterine bleeding, fibromyalgia, vitamin d deficiency, and required additional surgical and non-surgical interventions.

Manufacturer Narrative

1979, 2119="l".1928, 2116,1811, 2067, 1831="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 severe infection, pain, abdominal pain, pelvic pain, dyspareunia, erosion, exposure, recurrence of incontinence, urinary problems, hip pain, stomach pain, rectal pain, bleeding and nerve damage, vaginal fistula, crohn¿s disease, irritable bowel syndrome, ulcerative colitis, diarrhea, pelvic trauma, scarring, bleeding, nerve damage, peritonitis/sepsis, recurrent vaginal pain, uterine prolapse, urinary incontinence, urinary retention, vaginal vault prolapse, significant emotion and psychological injury and required additional surgical and non-surgical interventions.

• 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: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 10074241
• MDR Text Key: 191533225
• Report Number: 1018233-2020-03279
• 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
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2008
• Device Model Number: BRD400HK
• Device Catalogue Number: BRD400HK
• Device Lot Number: CVRF0106
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 5 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2007
• 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: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White