An adverse event was called in from the customer for an end user.The customer had a procedure on (b)(6) 2010 in which lube jelly was used and she had a possible reaction.The reporting customer said they do not have a record of the lot code and was not sure if the reaction was due to the lube jelly or other changes in medication.At this time, it cannot be confirmed that the product is sterile lubricating jelly manufactured by h and p industries, inc.And distributed by the (b)(4).Complaint investigation call id: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
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