UNNA-FLEX? ELASTIC UNNA BOOT 650941

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2016-08-01 for UNNA-FLEX? ELASTIC UNNA BOOT 650941 manufactured by Convatec Limited.

Event Text Entries

[50915441] Based on the available information, this event is deemed to be a reportable malfunction. No additional patient/ event details have been provided to date. Should additional information become available, a follow-up report will be submitted. Reported to the fda on august 01, 2016. (b)(4)..
Patient Sequence No: 1, Text Type: N, H10


[50915442] It was reported the primary package was shipped in good condition, however it was received broken at the client. Pictures were provided that appear to have an open weld on the carton.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1000317571-2016-00064
MDR Report Key5837841
Report SourceFOREIGN,OTHER
Date Received2016-08-01
Date of Report2016-07-15
Date of Event2016-07-15
Date Mfgr Received2016-07-15
Device Manufacturer Date2015-11-24
Date Added to Maude2016-08-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. JEANETTE JOHNSON
Manufacturer Street7900 TRIAD CENTER DRIVE SUITE 400
Manufacturer CityGREENSBORO NC 27409
Manufacturer CountryUS
Manufacturer Postal27409
Manufacturer Phone3365424681
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNNA-FLEX? ELASTIC UNNA BOOT
Generic NameBANDAGE, ELASTIC
Product CodeFQM
Date Received2016-08-01
Model Number650941
Lot Number1600030297
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCONVATEC LIMITED
Manufacturer AddressFIRST AVENUE DEESIDE INDUSTRIAL PARK DEESIDE, FLINTSHIRE CH52NU UK CH52NU


Patients

Patient NumberTreatmentOutcomeDate
10 2016-08-01

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