(b)(4).Additional information: fougera triple antibiotic ointment.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.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.Additional information was requested and the following was obtained: was there any medical or surgical intervention performed to address the finger swelling? there are now 3 similar cases of unusual swelling of the finger within 2 days of stitches in the ed.All had the same product use below.What is the physicians opinion of the contributing factors of the reaction? they are unclear as to the cause.One suggested that it may be a chemical response, but is not sure.Were any other products (adhesives / sutures from other product codes) used besides sutures from 698g and 1666g? if so, please provide the appropriate product code(s) and lot number(s).The other items used: neosporin ointment and chlorhexidine solution, adaptec with 4x4.We used chlorhexidine scrub, and fougera triple antibiotic ointment.It was recently reported that there have been three similar cases of unusual swelling of the finger within 2 days of stitches in the event description.Were all of the procedures finger laceration repairs? 3 had return ed visits with blister draining; initial visit (b)(6) 2016; 2nd visit: (b)(6) 2016.Are the event dates of any of the procedures available? see above initial ed visit and return 2nd ed visit.What are the causes of the finger lacerations? chain saw injury, knife injury (in kitchen), dog bite.
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It was reported that the patient underwent a finger laceration repair procedure on (b)(6) 2016 and the suture was used.Following the procedure, the patient experienced swelling at the site and returned to the emergency department with a blister draining on (b)(6) 2016.The doctor opined that they are unclear as to the cause and one suggested that it may be a chemical response, but is not sure.
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