[Risk Analysis for Bakri Postpartum Balloon in Clinic].

ABSTRACT

Object Analyze the adverse events of bakri postpartum balloon in order to promote its safety. Methods Collect and analyze the adverse events from the National Medical Device Adverse Event Monitoring Information System and the U.S. FDA MAUDE database. Chinese and English instructions for use are comparative analysed. Results In most cases, adverse events are balloon rupture and fluid leakage, which attribute to insufficient instruction. The description of the sequence that suturing the myometrium and filling the balloon is deficient. It should be moved gently to avoid puncturing or scratching the balloon with sharp instrument. Conclusion The product instruction improvement as well as training enhancement is recommended for safety consideration. Adverse events monitoring is suggested reinforce simultaneously.