MHRA Issues Alert for Uterine Sound

November 17, 2010
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a safety alert for uterine sounds manufactured by Rocket Medical before June 2008. Some lots of the device were incorrectly molded, resulting in a missing distal tip. The device will not function properly without the tip, and the shortened stem could cause injury. Furthermore, patients could be subjected to unnecessary additional procedures searching for a lost tip that was never present on the device, MHRA says.