Uterine Curettes

Question

On uterine curettes: 1. When did the TGA first receive a report about harmful outcomes caused by uterine curettes? 2. How many reports of adverse outcomes caused by uterine curettes has the TGA received to date, from doctors, hospitals or medical device sponsors? 3. How many reports of adverse outcomes caused by uterine curettes has the TGA received to date, from harmed women? 4. What proportion of all medical device adverse outcomes reported to the TGA (not limited to uterine curettes) are typically made by the general public? 5. The TGA noted to Senator Waters during the hearing that your office typically prioritises complaints received from members of the public - what does this priority response entail? 6. What level of investigation does the TGA typically complete when they receive reports of serious harm caused by a medical device (e.g. outcomes such as unexpected near fatality, or permanent loss of fertility)? Would this generally involve follow up with the harmed person and/or facility to gather further information about the adverse outcome, to assist with information gathering and assessing risk to the public?

Answer

Please see attached answer.

Documents

• Question with answer (PDF) (opens in a new tab)
• DHDA SQ26-002746.pdf (opens in a new tab)