(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What was the date of the procedure in 2011? what suture was used during procedure in 2011? what was the date of the second procedure? what suture was used during second procedure? if in your possession, may we have a copy of your operative report (2011, 2nd proc, and aug 2019) for each procedure to review which layer of tissue the suture was used? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact the surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide the surgeon¿s name, contact information and sign release of medical information form.Patient reported adverse event of hives, reaction possibly treated with steroid in 2011 reported via 2210968-2019-90131.Patient reported adverse event of hives, reaction and angioedema treated with steroid on unknown date reported via 2210968-2019-90134, 2210968-2019-90135 and 2210968-2019-90137.Patient reported adverse event of hives, reaction, angioedema treated with steroid in august 2019 and current hives reported via 2210968-2019-90138, 2210968-2019-90140 and 2210968-2019-90141.
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