Background
and Objectives: Three post-marketing clinical follow-up studies
were performed in Europe to confirm the safety and performance of four
nonprescription, nasal cleansing medical devices: Otrivin Sea Water (OSW)
pressurized spray, OSW with aloe vera (OSWAV), Otrisal 0.74% NaCl Metered-Dose
Spray (MDS), and Prorhinel spray.Material and Methods: Observational, single-arm, retrospective studies consisting of a single
online questionnaire were performed between July 2021 and December 2021.
Eligible participants were adults who used the device or supervised use of the
device in a participant under 18 years of age within 6 months of completing the
questionnaire. Demographics, safety, and device performance were assessed.Results: Based on questionnaires
submitted on OSW (n = 556), OSWAV (n = 555), Otrisal MDS (n = 555), and
Prorhinel (n = 555), proportions of users who reported safety events were 1.8%
for OSW, 2.3% for OSWAV, 1.4% for Otrisal MDS, and 2.0% for Prorhinel.
Proportions of users who indicated they were satisfied or very satisfied with
device performance ranged from 72.0% - 89.0% across all devices. Device performance for all
products was also supported for additional preventative and symptomatic uses
through exploratory analyses.Conclusions and
Significance: These data confirm device safety and performance of
OSW, OSWAV, Otrisal MDS, and Prorhinel for their intended uses.
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