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

Catalog Number BRD700SI

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 11/06/2018

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the patient experienced dyspareunia and recurrent urine stress incontinence.A partial removal of the tape (vaginal portion) was performed and the insertion of a fascial sling occurred.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿caution: federal (usa) law restricts this device to sale by or on the order of a physician.This product is intended for use only by physicians trained in the surgical procedures and techniques required for the treatment of female stress urinary incontinence and the implantation of nonabsorbable meshes.The physician is advised to consult the medical literature regarding techniques, complications, and hazards associated with the intended procedures.Description the ajust® adjustable single-incision sling system is a minimally invasive suburethral sling intended for the treatment of female stress urinary incontinence.The system consists of an adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for advancing the sling lock after adjustment.The device is terminally sterilized by ethylene oxide.Refer to figure 1 below for a detailed depiction of the ajust® system components.Figure 1: detailed depiction of the ajust® system components indications for use the ajust® adjustable single-incision sling system is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.Contraindications the ajust® sling system is contraindicated for patients experiencing any of the following conditions: pregnancy, urinary tract infection, anticoagulant therapy, and/or infection in the operative field.Warnings the implant procedure and the instrumentation associated with the surgical placement of the ajust® sling system carry an inherent risk of infection and bleeding, as do similar urological procedures.The use of surgical staples, clips, screws, or other non-suture attachment mechanisms not supplied with the ajust® sling system can damage the implant.After use, the product and its packaging should be treated as a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations." (b)(4).

Event Description

It was reported that the patient experienced dyspareunia and recurrent urine stress incontinence.A partial removal of the tape (vaginal portion) was performed and the insertion of a fascial sling occurred.

• Brand Name: AJUST¿ ADJUSTABLE SINGLE INCISION SLING (SINGLE)
• Type of Device: BARD ADJUST MINI FASCIAL 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: 8146834
• MDR Text Key: 129880343
• Report Number: 1018233-2018-05915
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• 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
• Date Manufacturer Received: 01/21/2019
• 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