UNKNOWN ALLEVYN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-29 for UNKNOWN ALLEVYN manufactured by Smith & Nephew Medical Ltd..

Event Text Entries

[185902068] It was reported that during a study which was comparing 3 different types of vaccination site bandages over time among both vaccinia-naive and vaccinia-experienced volunteers with respect to recovery of vaccinia, reactogenicity, tolerability, and ease of use. After vaccination, each volunteer was randomized to receive 1 of 3 types of vaccination site bandage: a 5#5-cm gauze bandage (curity gauze sponges sterile) attached with a single strip of adhesive tape, a 6. 5#5-cm semipermeable occlusive bandage with a gauze lining (opsite post-op), or a 7. 5#7. 5-cm foam hydrocellular bandage (allevyn adhesive). It was reported that the use of the allevyn dressing was more likely to fall off prematurely and leaked onto clothing.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8043484-2020-00229
MDR Report Key9896202
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-29
Date of Report2020-03-29
Date Mfgr Received2020-03-03
Date Added to Maude2020-03-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDR SARAH FREESTONE
Manufacturer Street101 HESSLE ROAD
Manufacturer CityHULL HU3 2BN
Manufacturer CountryUK
Manufacturer PostalHU3 2BN
Manufacturer Phone0447940038
Manufacturer G1SMITH & NEPHEW MEDICAL LTD.
Manufacturer Street101 HESSLE ROAD
Manufacturer CityHULL HU3 2BN
Manufacturer CountryUK
Manufacturer Postal CodeHU3 2BN
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN ALLEVYN
Generic NameDRESSING,WOUND,OCCLUSIVE
Product CodeNAD
Date Received2020-03-29
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW MEDICAL LTD.
Manufacturer Address101 HESSLE ROAD HULL HU3 2BN UK HU3 2BN


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-29

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