Catalog Number 8514 |
Device Problem
Cross Reactivity (1137)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Date 06/27/2017 |
Event Type
Injury
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Event Description
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On (b)(6) 2017 surgical technologist emailed indicates that she has a pre-existing sensitization to certain accelerators in use for certain surgical gloves.User was provided the gammex surgical gloves for three weeks and has been experiencing severe irritation on hands.User took a round of steroids which did not alleviate the irritation.User has stopped using the particular gloves and is using a cotton under glove liner which has allowed the irritation to abate.User is inquiring to possible use of accelerators for the product.
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Manufacturer Narrative
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10/12/2017 - a review of the batch record indicates that the product was compounded according to specification.No product contamination was found in reviewing samples and batch record.A test of the product from the lot in question was done to determine the presense of accelerators and antioxidant residues.Results of the evaluation indicate that no accelerators were detected and the antioxidants used in the formulation were present as expected.No root cause can be determined and no further action to be taken.
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Event Description
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(b)(6) 2017 surgical technologist emailed inidicates that she has a pre-existing sensitization to certain accelerators in use for certain surgical gloves.User was provided the gammex surgical gloves for three weeks and has been experiencing severe irritation on hands.User took a round of steriods which did not alleviate the irritation.User has stopped using the particular gloves asnd is using a cotton under glove liner which has allowed the irritation to abate.User is inquiring to possible use of accelerators for the product.
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Search Alerts/Recalls
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