Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Aesculap.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 094 04 18 000
  • Event Initiated Date
    2018-04-22
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12482
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    The aesculap ag received feedback from the market that the plastic sleeves of a strauss penis clamp 130mm - ef401r had stuck together after reprocessing. during complaint investigation it has been determined that the plastic sleeves of the returned instrument do not meet the valid specification. instead of the specified material silicone, the material pvc was used for the manufacturing of the sleeves. this could render affected instruments unusable after reprocessing. internal investigation conducted at the manufacturing plant revealed that the reported failure can be limited to the production period from february 2016 to october 2017. a definite identification of an affected product is not possible without the help of suitable equipment. we therefore ask you to consider all of your existing strauss penis clamp 130mm - ef401r to be potentially affected. the results of investigation revealed that there is no increased risk expected for patients who have been treated with the affected product. according to our internal distribution information your facility received applicable unit/s manufactured within the above mentioned production period. we kindly ask you to check if an affected instrument is currently in use at your facility. in case you have located an affected product: please ensure that these instruments are no longer used.

Device

Surgical PENIS CLAMP
  • Model / Serial
    EF401R
  • Product Description
    Surgical PENIS CLAMP
  • Manufacturer
    Aesculap

Manufacturer

Aesculap