MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ALIGN URETHRAL SUPPORT SYSTEM RETROPUBIC; ALIGN® URETHRAL SUPPORT SYSTEM RETROPUBIC

Model Number BRD100R

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Micturition Urgency (1871); Urinary Frequency (2275); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.No sample received.

Event Description

The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced frequent urination, pressure, urinary urgency, and frequency.The patient required non-surgical interventions.

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¿ 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." 2348, 2275, 1871, 2993, = "nl".H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

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• Brand Name: ALIGN URETHRAL SUPPORT SYSTEM RETROPUBIC
• Type of Device: ALIGN® URETHRAL SUPPORT SYSTEM RETROPUBIC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 11077601
• MDR Text Key: 223782271
• Report Number: 1018233-2020-06412
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 00801741016172
• UDI-Public: (01)00801741016172
• Combination Product (y/n): N
• PMA/PMN Number: K093747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

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: 08/30/2014
• Device Model Number: BRD100R
• Device Catalogue Number: BRD100R
• Device Lot Number: HUWG1782
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 8 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PELVISOFT® ACELLULAR COLLAGEN BIOMESH.; PELVISOFT® ACELLULAR COLLAGEN BIOMESH
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 102