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Field Safety Notice - Geistlich Bio-Oss Pen

6 June 2019

 

Geistlich Pharma AG has issued a Field Safety Notice for the Geistlich Bio-Oss Pen® (ref numbers 30661.1, 30662.1, 30671.1), having been informed by a customer that, after unscrewing the green filter cap from, a visible particle of green colour was seen on the outer barrel of the pen. In each of the reported cases, the particle was discovered by the attending physician before use. Geistlich has not received any reports of patient injury or harm for Geistlich Bio-Oss Pen®.

 

While these appear to be isolated incidents, Geistlich Pharma AG is providing this information to all users together with information on how to address the situation if it should arise.

 

Information on measures to be taken by the user:

 

  • When unscrewing the Geistlich Bio-Oss Pen® filter cap, please check for well visible and therefore easily detectable loose green/red residue or particles from the filter cap.
  • If a loose green/red particle from the filter cap are present, do not use the Geistlich Bio-Oss Pen® and return it to your distributor in its entirety (including any particles). Geistlich Pharma AG requires return of the Geistlich Bio-Oss Pen® concerned for examination purposes.

MHRA have asked the BDA to circulate the Field Safety Notice and for users to follow the recommended actions.

 

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