Model Number H7493941820350 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: used the first date of the month of the aware date as no event date was provided.
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Event Description
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It was reported that the seal packaging was compromised.A 3.50 x 20mm synergy xd was selected for use; however, it was noticed that the seal was broken.No patient complications were reported.
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Event Description
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It was reported that the seal packaging was compromised.A 3.50 x 20mm synergy xd was selected for use; however, it was noticed that the seal was broken.No patient complications were reported.
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Manufacturer Narrative
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(b3) date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.: the carton was not returned for analysis and is not expected to be returned.A photo was provided showing a lifted blue seal at the top of a shelf carton.H3 other text : photo.
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Search Alerts/Recalls
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