MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. FLAMAZINE CREAM 1% UK ONLY 500G JAR; CREAM, NASAL, TOPICAL, MECHANICAL ALLERGEN PARTICLE BARRIER

Catalog Number 66150155

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Injury (2348)

Event Date 01/01/1901

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: FLAMAZINE CREAM 1% UK ONLY 500G JAR
• Type of Device: CREAM, NASAL, TOPICAL, MECHANICAL ALLERGEN PARTICLE BARRIER
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10464015
• MDR Text Key: 204687096
• Report Number: 8043484-2020-02676
• Device Sequence Number: 1
• Product Code: NUP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 66150155
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other