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

Catalog Number BRD705SI

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

Patient Problems Incontinence (1928); Unspecified Infection (1930); Pain (1994); Sepsis (2067); Burning Sensation (2146)

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 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/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.¿ 1994 = "l".2348, 2993 = "nl".

Event Description

It was reported by the patient's attorney that as a result of having the product implanted, the patient had experienced vaginal bleeding, recurrence of urinary incontinence, persistent pain in groin, back, buttocks and legs.The patient was unable to have sexual intercourse because it was painful and the pain had affected the mobility.Patient had suffered from recurrent vaginal infection.Patient was admitted for flexible cystoscopy and mri on (b)(6) 2019 performed by the urogynecologist.Patient was reviewed on (b)(6) 2020 and was advised by the doctor that mri scan showed evidence of sepsis of transobturator tape.Doctor recommended the patient undergo removal of total removal of the tape and listed the patient for surgery.The patient underwent a surgical procedure to remove the tape on (b)(6) 2020 and the doctor performed the procedure.Since having the mesh removal procedure, the patient's symptoms of pain had remained.The patient had developed worsening pain in the legs, a burning sensation in the feet and a 'pins and needles' sensation in the arm.The patient had been diagnosed with a functional neurological disorder and the patient's incontinence had worsened since the removal procedure.The patient had also suffered from bladder spasms.It was stated that the symptoms had greatly affected the mobility and the patient had also suffered from low mood.It was also stated that the patient had struggled prior and following the mesh removal surgery.

• 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: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 12623088
• MDR Text Key: 276112408
• Report Number: 1018233-2021-80067
• 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
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2011
• Device Catalogue Number: BRD705SI
• Device Lot Number: HUTE0898
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2009
• 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: 46 YR