MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK + HALO

Model Number	BRD600HH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Prolapse (2475); Intermenstrual Bleeding (2665); Constipation (3274)
Type of Reportable Event	Serious Injury
Additional 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 align® to urethral support system may include, but are not limited to: postoperative hematoma, which may occur following the implant procedure temporary urinary retention, bladder outlet obstruction, and voiding difficulties associated with over-correction/too much tension placed on the mesh sling implant perforations or lacerations of vessels, nerves, bladder or any viscera, which may occur during introducer needle passage transitory irritation at the operative wound site, which may elicit a foreign body response that leads to inflammation, infection, or erosion of the implant." (b)(4).No sample received.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.Per additional information received, the patient has experienced infection, urinary urgency, pain with bowel movement, dysuria, urgency with urination, incomplete emptying, excision of suture at introitus, vaginal bleeding, rectocele, granulation tissue at vaginal cuff, posterior prolapse requiring splinting for bowel movements, severe constipation, urinary tract infection, clostridium difficile colitis infection, pelvic relaxation, mucosal separation of posterior repair, vaginal discharge, pelvic pain, perineal discomfort, odorous discharge, vaginal infection, sensation of pressure in bladder area, one surgical intervention and multiple nonsurgical interventions.

• Brand Name: ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK + HALO
• Common Device Name: ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK + HALO
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9180837
• Report Number: 1018233-2019-06394
• Device Sequence Number: 11416791
• Product Code: OTN
• UDI-Device Identifier: 00801741016233
• UDI-Public: (01)00801741016233
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2011
• Device Model Number: BRD600HH
• Device Catalogue Number: BRD600HH
• Device Lot Number: HUTL0796
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Weight: 92