Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Muscle Spasm(s) (1966); Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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The product is not available for return and the lot number was not reported.An assessment of the event was completed by (b)(6) medical personnel.The event is possibly related to the product.Based on all information, no causal factors can be determined and no conclusion can be drawn.
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Event Description
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A dental office reported a patient received an inferior alveolar injection and experienced limited opening of their mouth and sore mass muscles immediately after the anesthetic wore off.Lidocaine 2% 1:100,000 was used and the pen was dialed to the range of 16-18.It was painful for the patient to open their mouth for 2-4 weeks.The patient required steroids and may have required a nightguard.
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Manufacturer Narrative
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The product was not returned and the lot number was not reported.The manufacturer's investigation identified no causal factors and no conclusion can be drawn.
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Search Alerts/Recalls
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