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

Catalog Number BRD700SI

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

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

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the patient had recurrent stress incontinence for several years that had re-appeared in (b)(6) 2019.The recurrent incontinence was confirmed through video urodynamic.The ajust device was inserted in the patient in 2011.The patient is awaiting further surgery to treat stress incontinence.

Manufacturer Narrative

The device was not returned for evaluation.A potential root cause of the reported event could be that the physician did not have proper knowledge of the patient's entire medical needs due to which cystocele repair was not performed but was needed before the device implant surgery, resulting in recurrent stress incontinence and need for additional surgery.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: "anatomical distortion can result from pelvic organ prolapse.If the patient requires cystocele repair, it should be performed prior to the implantation of the sub-urethral sling.".

Event Description

It was reported that the patient had recurrent stress incontinence for several years that had re-appeared in may 2019.The recurrent incontinence was confirmed through video urodynamic.The ajust device was inserted in the patient in 2011.The patient is awaiting further surgery to treat stress incontinence.

• Brand Name: AJUST¿ ADJUSTABLE SINGLE INCISION SLING (SINGLE)
• Type of Device: AJUST
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9119167
• MDR Text Key: 162470670
• Report Number: 1018233-2019-05941
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K092607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BRD700SI
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention