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

Catalog Number BRD705SI

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

Patient Problems Stacking Breaths (1593); Abdominal Pain (1685); Asthma (1726); Erosion (1750); Chest Pain (1776); Cyst(s) (1800); Fistula (1862); Micturition Urgency (1871); Hematoma (1884); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Swelling (2091); Tachycardia (2095); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Distress (2329); Discomfort (2330); Injury (2348); Irritability (2421); Prolapse (2475); Hematuria (2558); Dysuria (2684); Fluid Discharge (2686); Fibrosis (3167); Dyspareunia (4505); Limb Fracture (4518); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Per direction by fda in an email dated june 26, 2019, this emdr is being filed to submit new information obtained prior to a letter received on may 15, 2019, regarding the revocation of the asr for exemption e2013025.It was agreed upon with the fda that the date of awareness would be the date of the email received, which is june 26, 2019.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." (b)(4).

Event Description

Alleged mesh complaint - more information to be provided.The patient¿s attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.Reason for report: revocation of asr, report id number: complaint (b)(4), corresponding exemption number: e2013025.

Manufacturer Narrative

2119 = "l".2123, 2091 ="nl".

Event Description

Per additional information received on 08feb2021, the patient experienced pain, suffering, loss of amenity, urinary retention, mildly tender 2cm lump in the vagina, cystitis (25mm), vaginal wall hematoma, vaginal thrush, dyspareunia, tenderness, sub-urethral scar tissue, 1.5 cm cystic collection, urethral diverticulum, recurring urinary tract infections, discomfort when voiding, mesh exposure, micturition urgency, pain in the area of the incision, pubis, thighs, bottom, behind the urethra and inside the vagina bilaterally, dysuria, suprapubic pain, dull ache in the bottom radiating down to the upper thighs bilaterally and a pain in right labia.Additionally the patient required surgical and non surgical interventions.

Manufacturer Narrative

1862, 1884 = "l" 2330, 2475, 2684, 2686 ="nl".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 20may2021, the patient experienced urinary infections, discomfort in the region of the urethral scar, ache in her lower abdomen, twinge in the vagina, fibrosis around the incision, vaginal wall hematoma, mild tenderness in vagina, cysts observed in the anterior vaginal wall, slight prominent skin tag related to the scar, dyspareunia, urethral diverticulum, periurethral swelling, acute urinary retention, pain and bladder spasms, thrashes around, closed fracture toes left foot, recurrent urinary tract infection, knee pain, abdominal pain, prolapsed "bladder", fistula, pubic pain, urinary leakage, urethral discharge, nonrelaxing of the urethral sphincter, several urethral and vaginal pain, apyrexial, slightly tachycardiac, bladder diverticulum, unpleasant green/yellow discharge from the urethra and required surgical and non-surgical interventions.

Event Description

Per additional information received via on 29sep2021, the patient experienced severe pain at urethral meatus, deep bladder pain, distress, lower abdominal distention, urinary frequency, back pain, suicidal ideation, alcohol intoxification, painful while passing the urination, mixed incontinence, smear, hematuria, chest pain, leg swelling, palpitations, cough, mild cystocele, hypermobility, twinge sensation in vagina, dragging pain in buttocks, asthma, lesions on back, breathlessness, and required surgical and non-surgical interventions.

Manufacturer Narrative

2091, 2329, 2558, 1776, 2467="nl".Correction: a2.

Event Description

Per additional information received on (b)(6) 2021, the patient has experienced small amount of urine leakage, lack of urinary sensation, dyspareunia, systemic symptoms of infection, fibrous and chronic inflammation, and required additional surgical and non-surgical interventions.

Manufacturer Narrative

1932, 1930="l".2225="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: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 8760861
• MDR Text Key: 150028940
• Report Number: 1018233-2019-03633
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 00801741168017
• UDI-Public: (01)00801741168017
• 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,Followup
• Report Date: 11/11/2021

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: 09/30/2012
• Device Catalogue Number: BRD705SI
• Device Lot Number: HUUI1498
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 6 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: 02/08/2021; 05/20/2021; 09/29/2021; 11/02/2021
• Supplement Dates FDA Received: 02/11/2021; 06/01/2021; 10/07/2021; 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2011
• 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: 37 YR
• Patient Sex: Female
• Patient Race: White