UNKNOWN TEDS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2012-07-12 for UNKNOWN TEDS manufactured by Covidien, Covidien Manufacturing.

Event Text Entries

[21261625] It was reported to covidien on (b)(6) 2012 that a customer had an issue with a ted compression stocking. The customer states that the stockings were used during hip surgery. The patient experienced a pressure wound/decubitus above the heel where the stocking had been tight.
Patient Sequence No: 1, Text Type: D, B5


[21357430] Submit date: (b)(4) 2012. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3009211636-2012-00003
MDR Report Key2665117
Report Source01,06
Date Received2012-07-12
Date of Report2012-06-19
Date of Event2011-04-01
Report Date2012-06-19
Date Reported to Mfgr2012-06-19
Date Mfgr Received2012-06-19
Date Added to Maude2012-10-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Manufacturer ContactEDWARD ALMEIDA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5084524151
Manufacturer G1COVIDIEN, COVIDIEN MANUFACTURING SOLULFONS SA
Manufacturer StreetEDIFICIO 820 CALLE #2 ZONA FRANCA
Manufacturer CityALAJUELA 20101
Manufacturer CountryCS
Manufacturer Postal Code20101
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN TEDS
Generic NameTED COMPRESSION STOCKING
Product CodeDWL
Date Received2012-07-12
Model NumberUNKNOWN TED
Catalog NumberUNKNOWN TED
Lot NumberUNKNOWN
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN, COVIDIEN MANUFACTURING
Manufacturer AddressALAJUELA 20101 CS 20101


Patients

Patient NumberTreatmentOutcomeDate
10 2012-07-12

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