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

Catalog Number BRD700SI

Device Problems Material Erosion (1214); Patient-Device Incompatibility (2682)

Patient Problems Erosion (1750); Failure of Implant (1924)

Event Date 11/26/2018

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 vaginal mesh required removal due to erosion.

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: ¿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." correction: concomitant medical products and device evaluated by mfr.

Event Description

It was reported that the vaginal mesh required removal due to erosion.

• Brand Name: AJUST¿ ADJUSTABLE SINGLE INCISION SLING (SINGLE)
• Type of Device: ADJUST
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8197586
• MDR Text Key: 131442408
• Report Number: 1018233-2018-06181
• 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: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• 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: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention