MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 AJUST® ADJUSTABLE SINGLE-INCISION SLING

Catalog Number BRD700SI

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

Patient Problems Abdominal Pain (1685); Anemia (1706); Cyst(s) (1800); Fever (1858); Micturition Urgency (1871); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Blurred Vision (2137); Vomiting (2144); Dizziness (2194); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Depression (2361); Prolapse (2475); Abdominal Cramps (2543); Dysuria (2684); Constipation (3274); Urinary Incontinence (4572); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

The sample was not returned.The lot number is unknown; therefore, the device history record could not be reviewed.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 ajust® sling system may include, but are not limited to: 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 over-correction/typically too much tension placed on the implant.Perforations or lacerations of vessels, nerves, bladder, bowel, urethra, vagina, rectum 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." 2348, 2993 = "nl".Sample not received.

Event Description

The patient's attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.

Event Description

Per additional information received on (b)(6) 2021, the patient has experienced recurrent urinary tract infections, urinary incontinence, pain, mild abdominal discomfort, dysuria, hypogastric pain, urinary frequency, urinary urgency, groin pain, stress incontinence, abdominal and lumbar pain, urge incontinence, facial swelling, blurred vision on the right side, dyspnoea, dystrophia unguium, elbow pain, fever with vomiting, lightheadedness, infection, symptoms of dizziness, chronic depression, mild ache in kidney, menopausal symptoms, nausea, abdominal cramps, constipation, smelly urine, unspecified peripheral vertigo, hypercholesterolemia, chronic cystitis and required additional surgical and non-surgical interventions.

Manufacturer Narrative

2120, 1930, 1994, 1928="l" 2330, 2684, 2091="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 (b)(6) 2022, the patient has experienced depression, anxiety, dsyuriua, anaemia, groin pain, infection, urinary incontinence, recurrent urinary tract infection, urine culture- e.Coli, hypercholesterolemia and required additional surgical and non-surgical interventions.

Manufacturer Narrative

2361, 1970, 2543, 3274, 1871, 2275, 1685, 2137, 1800, 2564, 1858, 2144, 2194, 2519, 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 via medical records on 18oct2022, the patient has experienced chronic pain, urinary retention, urinary dysfunction, dysuria, nocturia, urge incontinence, recurrent urinary tract infection, chronic cystitis, mild chronic inflammation, exacerbated urinary incontinence, extended spectrum beta-lactamase resistant bacterial infection, urine culture ¿ escherichia coli, cystocele, stress incontinence, depression, vaginal wall prolapse, throat infection, carpal tunnel syndrome, pelvic floor repair, hypercholesterolemia, sacrocolpopexy, vesico rectal prolapse, fibroid uterus, incomplete bladder emptying, anaemia, dysuria, groin pain and mesh complications and required additional surgical and non-surgical interventions.

Manufacturer Narrative

2119, 1932, 1735 = "l".2475, 1706 = "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: AJUST® ADJUSTABLE SINGLE-INCISION SLING
• Type of Device: AJUST® ADJUSTABLE SINGLE-INCISION SLING
• 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: juan velez ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 11761932
• MDR Text Key: 248790831
• Report Number: 1018233-2021-80037
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 00801741168000
• UDI-Public: (01)00801741168000
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K092607
• 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: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BRD700SI
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 57 KG