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 Pain (1994); Injury (2348); Disability (2371)

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.¿ (b)(4).

Event Description

It was reported by the patient's attorney that as a result of having the product implanted the patient has experienced pain, injury, suffering, disability, impairment, urinary tract infections, pain in legs, back, both hips, and vagina, pain and bleeding with sexual intercourse and required surgical and non-surgical interventions.

Manufacturer Narrative

Correction: mdr date of awareness.

• 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
• MDR Report Key: 10513585
• MDR Text Key: 206294566
• Report Number: 1018233-2020-05789
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 00801741168017
• UDI-Public: (01)00801741168017
• Combination Product (y/n): N
• PMA/PMN Number: K092607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

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: 09/01/2013
• Device Catalogue Number: BRD705SI
• Device Lot Number: HUVH0987
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 15 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/29/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 08/28/2020
• Supplement Dates FDA Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR