FDA Expert Discusses Adverse Event Reporting Requirements


FDAThis case involves a middle-aged female in Maryland who presented to the hospital with bleeding after defecation caused by hemorrhoids. The decision was made to perform a hemorrhoidopexy to correct her condition. Following the procedure, the woman complained of an inability to void her bladder, which was treated with the insertion of a catheter. Once the catheter was inserted, a large amount of blood was discovered in the patient’s bladder. The patient was taken in for surgery to diagnose the source of the bleeding, at which point a rectal wall hematoma was discovered. It was claimed that the injury was caused by a defectively designed hemorrhoidectomy stapler, and that the manufacturer of the device had failed to disclose the issue in accordance with FDA requirements.

Question(s) For Expert Witness

  • 1. Are you specifically familiar with the device described in the above case overview?
  • 2. What processes must be adhered to in order to ensure the safe and appropriate use of the device in question?

Expert Witness Response E-007664

Expert-ID: E-007664

I am not specifically familiar with this brand, but generally understand the procedure and use of this medical device, the use of staple or alternate closure devices in the place of sutures as well as the manufacturer responsibility once made aware of the issue. There are requirements for the manufacturer to provide adequate instructions for use which should provide all relevant information for the safe and appropriate use of the device. In addition, the manufacturer must have a risk analysis of the potential severity and predicted occurrence of any issues that have been identified. This could also identify any required clinician training or other information regarding this issue. After this issue occurred, the manufacturer would have an obligation to report this issue to the FDA as a Medical Device Report (MDR) within the timelines required by regulations due to the additional procedures required. This would also require an investigation of the issue by the manufacturer and should trigger a review of the risk associated with the use of the device.

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