SMITH & NEPHEW MEDICAL LTD. FLAMAZINE CREAM 1% UK ONLY 500G JAR; CREAM, NASAL, TOPICAL, MECHANICAL ALLERGEN PARTICLE BARRIER
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Catalog Number 66150155 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Necrosis (1971); Injury (2348)
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Event Date 01/01/1901 |
Event Type
Injury
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Event Description
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It was reported that a case of toxic epidermal necrolysis was reported in a (b)(6) male patient which occurred in 2006 after use of multiple suspect drugs for toxic epidermal necrolysis and other unknown indication, which were used for an unknown period.The patient¿s relevant medical history includes: drug hypersensitivity, chest infection, pneumonia for which the patient was hospitalized also nephropathy which is ongoing, diabetes mellitus (non-insulin dependent) which is poorly managed and ongoing and alcoholic which is also ongoing.This case has been classed as serious and medically significant and the outcome is unknown.Due to the lack of information provided it has not been possible at this time to confirm whether the suspect drug sulfadiazine silver is a smith & nephew product.
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Manufacturer Narrative
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H10: in reviewing the subject product details, it was determined that this event was reported to fda-cdrh in error.The referenced part number is a pharmaceutical product and not a medical device.Additionally, the product is not licensed/approved for sale in the us.The case has been logged in our complaint system and pharmacovigilance database.The event occurred in the uk and was received via evweb which is a secure electronic gateway to the european medicines agency and all eea competent authorities for reporting purposes.Therefore, there are no additional reporting obligations for fda.
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Search Alerts/Recalls
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