Pharmacy technician had an allergic reaction about 2 months ago from an undetermined cause (they suspected the surgical hand sanitizer or the glove).At that time the technician was removed from all duties requiring garbing for sterile compounding; and she was referred to an allergist and dermatologist.After treatment and clearance, on (b)(6) 2017 the tech was scheduled for a full eight hour shift that required garbing with the surgical gloves.Later that day her hands became red, swollen, weepy (almost twice their normal size), and difficult to make a closed fist.Since this was the second occurrence of the reaction and the technician had clear demarcation from her wrist to her fingernails, it was determined to be related to the gloves.The technician was pulled from all duties requiring the surgical gloves, resumed her prior topical treatment.Her skin is now dry, cracked, and flaking.
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Originally it was reported that the pharmacy technician experienced the reaction to catalog# 2d72pt60x, lot# ts16050054; and this is the information that was provided on the initial medwatch. since then however, it was learned that the actual catalog# involved is 2d72pt70x, lot# ts16090363. the manufacture date for this catalog number is (b)(6) 2016, and the expiration date is august 2019. the device history record of complaint lot ts16090363 was reviewed, and the lot was inspected and released in compliance with all requirements.Historical trending was done.A representative sample (unopened package) of catalog# 2d72pt70x / lot# ts16090363 was received and evaluated by visual inspection.The sample was submitted for primary skin irritation testing, and passed the test.The actual root cause could not be determined.The protexis pi gloves have passed a series of tests prescribed by regulatory agencies for the intended use.However the possibility of an individual experiencing a reaction to certain chemicals used during the manufacturing process cannot be ruled out.There has been no change to the glove formulation or production process.We will continue to monitor complaints for any trends which might require further investigation.
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