Testicular implants and inflatable vaginal stents 를 위한 안전성 경고 / 현장 안전성 서한

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.

The German medical device regulatory authority informed MHRA on Friday 18 September 2015 that a German notified body had temporarily suspended the marketing and distribution of all medical devices manufactured by Silimed lndustria de lmplantes Ltda.A recent inspection of the manufacturing facility by the notified body identified particles on the surface of some devices. See MHRA’s alert MDA/2015/034 published on Friday 25 September 2015.It has subsequently been established that testicular implants and vaginal stents manufactured by Coloplast A/S are made under sub-contract by Silimed lndustria de lmplantes Ltda and so are also affected by the temporary suspension.MHRA is investigating in collaboration with other European regulators and recommends that none of these devices should be implanted until further advice is issued.The manufacturer issued a field safety notice (FSN) dated 9 October 2015.