Hello Anon-
If you are a healthcare facility or manufacturer or importer/ distributor, you MUST use Form 3500A to report adverse events that contributed or may have contributed to <g class="gr_ gr_267 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar only-ins doubleReplace replaceWithoutSep" id="267" data-gr-id="267">death</g> or serious injury to the user or to the patient.
Since you stated that the event at hand does not contribute to a death or serious injury, you do not need to file a MedWatch report. However, your term "important event" is quite skeptical and subjective. Hence, it is imperative that a sound justification is documented showing that your event does not cause risk of death, serious injury or malfunction.
If the event is related to multiple units or lots, you have a bigger problem. Perform a Health Hazard Assessment (HHE) and act accordingly.
Regards!
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Phani Puppala
Quality Regulatory Specialist
Franklin MA
United States
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Original Message:
Sent: 15-Oct-2018 15:31
From: Anonymous Member
Subject: MDR reporting form 3500 vs 3500 A
This message was posted by a user wishing to remain anonymous
Is manufacturer allowed to use form 3500 (voluntary) or only 3500A(mandatory) if they wish to report an event that is important, but does not cause death or considered life threatening? Or, is 3500 only reserved for consumers?